Heart FailurePRO-HFNCT04164004
Patient-Reported Outcome Measurement in Heart Failure Clinic
A study testing Kansas City Cardiomyopathy Questionnaire-12 in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Kansas City Cardiomyopathy Questionnaire-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,249 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stanford Heart Failure clinic visit during enrollment period
Who cannot join
- Seen in amyloid clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital & Clinics
Stanford, California, 94305
About this study
Official title: Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.
- Conditions
- Heart Failure
- Being tested
- Kansas City Cardiomyopathy Questionnaire-12
- Keywords
- Quality of life, Patient-reported outcomes, Quality of care, Implementation research
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kansas City Cardiomyopathy Questionnaire-12Other
Also called KCCQ-12
Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) | Experimental | Patients in the KCCQ-12 arm will undergo KCCQ-12 assessment of patient-reported heart failure health status in the electronic health record at each heart failure clinic visit beginning at the start of the trial. Assessment results will be available to clinicians in the electronic health record when making treatment decisions during each clinic visit. Receives: Other: Kansas City Cardiomyopathy Questionnaire-12 |
| Usual Care | Active comparator | Patients in the usual care arm will not complete KCCQ-12 assessments in the electronic health record with clinic visits. They will complete a KCCQ-12 assessment at baseline that will not be available to the treating clinician. Receives: Other: Kansas City Cardiomyopathy Questionnaire-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire-12 Score
The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Domain scores are scaled 0-100, and the overall score is the average of the domain scores. For the domain and overall scores, 0 denotes the lowest reportable health status and 100 the highest. Higher values represent a better outcome.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Kansas City Cardiomyopathy Questionnaire-12 Response Rate
Frequency of KCCQ-12 response at each clinic visit among patients in the KCCQ-12 arm. This will be the primary implementation outcome. The rate will be calculated as the number of responses divided by the total number of requests to complete the survey.
Measured: 1 year
Secondary outcomes (32)
Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction
Beta-blocker therapy use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Measured: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction
Among those patients on beta-blocker therapy, the specific medication and dose will be collected.
Measured: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
Use of any renin-angiotensin-aldosterone system inhibitors among the sub-group of patients with left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
Among those patients on renin-angiotensin-aldosterone system inhibitors with left ventricular ejection fraction ≤ 40%, the specific medication and dose will be collected.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on Mineralocorticoid Receptor Antagonist therapy, the specific medication and dose will be collected.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction > 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
Among the sub-group of patients with left ventricular ejection fraction > 40% on Mineralocorticoid Receptor Antagonist therapy, the specific medication and dose will be collected.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
Hydralazine/nitrate use among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
Among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40% on hydralazine/nitrate therapy, the specific dose will be collected
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
Sacubitril-valsartan use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on sacubitril-valsartan, the specific dose will be collected.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Preserved/Mid-range Ejection Fraction.
Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Left Ventricular Ejection Fraction > 40%.
Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction > 40%.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy
Ivabradine use among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy
Among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm on ivabradine, the medication dose will be collected.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients With a Implantable Cardiac Defibrillator Among Patients With Reduced Ejection Fraction
Presence of an implantable cardiac defibrillator among the sub-group of patients with left ventricular ejection fraction ≤ 35%.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients With a Cardiac Resynchronization Therapy Device Among Patients With Reduced Ejection
Presence of cardiac resynchronization therapy among the sub-group of patients with left ventricular ejection fraction ≤ 35% with electrocardiogram findings consistent with a left bundle branch block with QRS width >150ms.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients With Reduced Ejection Fraction
Referral to cardiac rehabilitation among the subgroup of patients with left ventricular ejection fraction ≤ 35%.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Number of Medication Adjustments Per Heart Failure Clinic Visit
The number of medication adjustments made at each heart failure clinic visit. These will include dose changes, new medications, and discontinuation of prior medicines.
Measured: Within one year post-randomization
Average Daily Loop Diuretic Dose
The specific loop diuretic and dose will be collected. Diuretic doses will be converted into a standard total daily dose of loop diuretic.
Measured: Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization
Count of Hospitalizations Per Patient
Heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Emergency Department Visits Per Patient
Stanford emergency department visits during the follow-up period.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Heart Failure Clinic Visits Per Patient
Stanford heart failure clinic visits during the followup period.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Telephone Encounters Per Patient
Stanford heart failure telephone encounters during the follow-up period.
Measured: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation
Formal work-up for heart transplant or LVAD (left ventricular assist device) eligibility
Measured: Within one year post-randomization
Quality of Patient Clinic Experience
The results from a 10-question survey with ordinal responses regarding patient experience in clinic to a sub-study of all participants enrolled after the first month.
Measured: First clinic visit post-randomization within approximately 14 days
Correlation Between Clinician and Patient Perception of Health Status
Patient and clinician perception of health status will be collected. Patient perception is collected via the KCCQ-12 while clinicians will be surveyed regarding health status. We will determine the correlation between patient and clinician perception using an ordinal scale. We will compare correlation across arms.
Measured: First clinic visit post-randomization within approximately 14 days
Cardiovascular Diagnostic Test Frequency
Number of diagnostic tests performed between randomization and one year post-randomization. Diagnostic tests include cardiovascular imaging (echocardiography, MRI, cardiac CT, nuclear scan), invasive testing (coronary angiography, right heart catheterization), or ambulatory rhythm monitoring.
Measured: Within one year post-randomization
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Heart Failure or Cardiomyopathy
The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms among patients with heart failure or cardiomyopathy The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Sub-optimal Health Status at Baseline
The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms among patients with baseline KCCQ <100 at baseline
Measured: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Number of Total Heart Failure Medication Adjustments
The total number of heart failure medication adjustments. Heart failure medications include beta-blockers, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, sodium/glucose cotransporter-2 inhibitors, hydralazine/nitrate therapy, ivabradine, or loop diuretics.
Measured: Number of medication adjustments from randomization to one year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Aug 2021
- Primary completion10 Oct 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Sandhu, Stanford University
- Investigators
- Alexander T Sandhu, MD, MS, Principal investigator, Instructor of MedicinePaul A Heidenreich, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164004
- Sponsor's protocol ID
- 53713
- Acronym
- PRO-HF
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2019
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandhu AT, Calma J, Skye M, Kalwani N, Zheng J, Schirmer J, Din N, Brown Johnson C, Gupta A, Lan R, Yu B, Spertus JA, Heidenreich PA. Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial. Circulation. 2024 May 28;149(22):1717-1728. doi: 10.1161/CIRCULATIONAHA.124.069624. Epub 2024 Apr 7.
PubMed 38583147Brown-Johnson C, Calma J, Amano A, Winget M, Harris SR, Vilendrer S, Asch SM, Heidenreich P, Sandhu AT, Kalwani NM. Evaluating the Implementation of Patient-Reported Outcomes in Heart Failure Clinic: A Qualitative Assessment. Circ Cardiovasc Qual Outcomes. 2023 May;16(5):e009677. doi: 10.1161/CIRCOUTCOMES.122.009677. Epub 2023 Apr 28.
PubMed 37114990Sandhu AT, Zheng J, Kalwani NM, Gupta A, Calma J, Skye M, Lan R, Yu B, Spertus JA, Heidenreich PA. Impact of Patient-Reported Outcome Measurement in Heart Failure Clinic on Clinician Health Status Assessment and Patient Experience: A Substudy of the PRO-HF Trial. Circ Heart Fail. 2023 Feb;16(2):e010280. doi: 10.1161/CIRCHEARTFAILURE.122.010280. Epub 2022 Nov 5.
PubMed 36334312
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic
- ClinicalTrials.gov ID
- NCT04164004
- Acronym / sponsor ID
- PRO-HF / 53713
- Conditions
- Heart Failure
- Keywords
- Quality of life, Patient-reported outcomes, Quality of care, Implementation research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,249 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) | Experimental | Other: Kansas City Cardiomyopathy Questionnaire-12Patients in the KCCQ-12 arm will undergo KCCQ-12 assessment of patient-reported heart failure health status in the electronic health record at each heart failure clinic visit beginning at the start of the trial. Assessment results will be available to clinicians in the electronic health record when making treatment decisions during each clinic visit. |
| Usual Care | Active comparator | Other: Kansas City Cardiomyopathy Questionnaire-12Patients in the usual care arm will not complete KCCQ-12 assessments in the electronic health record with clinic visits. They will complete a KCCQ-12 assessment at baseline that will not be available to the treating clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stanford Heart Failure clinic visit during enrollment period
Key exclusion criteria (1 listed)
- Seen in amyloid clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire-12Also: KCCQ-12Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits. | Other | Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm), Usual Care |
Primary outcome
Kansas City Cardiomyopathy Questionnaire-12 Score
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Domain scores are scaled 0-100, and the overall score is the average of the domain scores. For the domain and overall scores, 0 denotes the lowest reportable health status and 100 the highest. Higher values represent a better outcome.
Kansas City Cardiomyopathy Questionnaire-12 Response Rate
Time frame: 1 year
Frequency of KCCQ-12 response at each clinic visit among patients in the KCCQ-12 arm. This will be the primary implementation outcome. The rate will be calculated as the number of responses divided by the total number of requests to complete the survey.
32 secondary outcomes
Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction
Time frame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction
Time frame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Preserved/Mid-range Ejection Fraction.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Left Ventricular Ejection Fraction > 40%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients on Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Median Dose of Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Percentage of Patients With a Implantable Cardiac Defibrillator Among Patients With Reduced Ejection Fraction
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients With a Cardiac Resynchronization Therapy Device Among Patients With Reduced Ejection
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients With Reduced Ejection Fraction
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Number of Medication Adjustments Per Heart Failure Clinic Visit
Time frame: Within one year post-randomization
Average Daily Loop Diuretic Dose
Time frame: Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization
Count of Hospitalizations Per Patient
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Emergency Department Visits Per Patient
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Heart Failure Clinic Visits Per Patient
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Count of Telephone Encounters Per Patient
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation
Time frame: Within one year post-randomization
Quality of Patient Clinic Experience
Time frame: First clinic visit post-randomization within approximately 14 days
Correlation Between Clinician and Patient Perception of Health Status
Time frame: First clinic visit post-randomization within approximately 14 days
Cardiovascular Diagnostic Test Frequency
Time frame: Within one year post-randomization
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Heart Failure or Cardiomyopathy
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Sub-optimal Health Status at Baseline
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Number of Total Heart Failure Medication Adjustments
Time frame: Number of medication adjustments from randomization to one year post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38583147Sandhu AT, Calma J, Skye M, Kalwani N, Zheng J, Schirmer J, Din N, Brown Johnson C, Gupta A, Lan R, Yu B, Spertus JA, Heidenreich PA. Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial. Circulation. 2024 May 28;149(22):1717-1728. doi: 10.1161/CIRCULATIONAHA.124.069624. Epub 2024 Apr 7.
- Derived from this study: PubMed 37114990Brown-Johnson C, Calma J, Amano A, Winget M, Harris SR, Vilendrer S, Asch SM, Heidenreich P, Sandhu AT, Kalwani NM. Evaluating the Implementation of Patient-Reported Outcomes in Heart Failure Clinic: A Qualitative Assessment. Circ Cardiovasc Qual Outcomes. 2023 May;16(5):e009677. doi: 10.1161/CIRCOUTCOMES.122.009677. Epub 2023 Apr 28.
- Derived from this study: PubMed 36334312Sandhu AT, Zheng J, Kalwani NM, Gupta A, Calma J, Skye M, Lan R, Yu B, Spertus JA, Heidenreich PA. Impact of Patient-Reported Outcome Measurement in Heart Failure Clinic on Clinician Health Status Assessment and Patient Experience: A Substudy of the PRO-HF Trial. Circ Heart Fail. 2023 Feb;16(2):e010280. doi: 10.1161/CIRCHEARTFAILURE.122.010280. Epub 2022 Nov 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander T Sandhu, MD, MS principal investigator
Instructor of Medicine
Paul A Heidenreich, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kansas City Cardiomyopathy Questionnaire-12 in people with Heart Failure, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire-12 Score (time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164004, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.