Heart Failure; With DecompensationNCT03657459
Danger Signs in Heart Failure- Effects of Video Education
A study testing Danger Signs of Heart Failure Videos in people with Heart Failure; With Decompensation, run by The Cleveland Clinic at 8 sites in United States.
Trial summary
Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Danger Signs of Heart Failure Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Jul 2018to 31 May 2022
- 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
- Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization,
- Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed,
- Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed,
- Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.
Who cannot join
- Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration),
- Plans to discharge to skilled nursing facility or hospice care,
- Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV HF),
- Hospitalized but at admission, in New York Heart Association functional class I or II HF
- Post-cardiac transplantation or ventricular assist device placement,
- Currently enrolled in another experimental HF research study,
- Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate < 15 mL/minute/1.73 m2,
- A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic main campus
Cleveland, Ohio, 44195
Cleveland Clinic Marymount Hospital
Garfield Heights, Ohio, 44125
Medical Center Navicent Health
Macon, Georgia, 31201
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Cleveland Clinic Medina Hospital
Medina, Ohio, 44256
Cleveland Clinic South Pointe Hospital
Warrensville Heights, Ohio, 44122
WellSpan Health
York, Pennsylvania, 15198
About this study
Official title: Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education
Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.
Read the detailed description
The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- Danger Signs of Heart Failure Videos
- Keywords
- video education, self care management, symptom recognition
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danger Signs of Heart Failure VideosBehavioural
Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors
| Study group | Role | What they receive |
|---|---|---|
| usual care group | No intervention | Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs |
| video education group | Active comparator | Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions) Receives: Behavioral: Danger Signs of Heart Failure Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Measured: up to 30 days
Secondary outcomes (29)
Number of Participants With HF-related Hospitalization
Total number of participants post-discharge with HF-related hospitalization
Measured: up to 30 days
Number of Participants With HF-related ED Visits
Number of participants with post-discharge HF-related ED visits
Measured: up to 30 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Measured: up to 30 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Measured: up to 90 days
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Measured: up to 90 days
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
Measured: up to 90 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Measured: up to 90 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Measured: up to 180 days
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Measured: up to 180 days
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
Measured: up to 180 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Measured: up to 180 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Measured: up to 30 days
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Measured: up to 30 days
Number of Participants With All-cause ED Visits
Number of participants with post-discharge all-cause ED visits
Measured: 30 days
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause deaths
Measured: up to 30 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Measured: up to 90 days
Number of Participants With All-cause Hospitalization
Number of participants with post-discharge all-cause hospitalization
Measured: up to 90 days
Number of Participants With All-cause ED Visits
Number of participants post-discharge with all-cause ED visits
Measured: up to 90 days
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause death
Measured: up to 90 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Measured: up to 180 days
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Measured: up to 180 days
All-cause ED Visits at 180 Days
Number of participants post-discharge with all-cause ED visits
Measured: up to 180 days
All-cause Death at 180 Days Post Discharge
Number of participants post-discharge with all-cause death
Measured: up to 180 days
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.
Measured: up to 30 days
Dyspnea at 30 Days Post Discharge
PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.
Measured: 30 days
Fatigue at 30 Days Post Discharge
10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).
Measured: to 30 days
Self-efficacy for Managing Symptoms at 30 Days Post Discharge
PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy
Measured: 30 days
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times
Measured: 30 days
Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)
Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start26 Jul 2018
- Primary completion20 Oct 2021
- Study completion31 May 2022
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.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled prospective trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Wellflix, Inc.
- Responsible party
- Principal investigator, Nancy M. Albert, Ph.D., The Cleveland Clinic
- Investigators
- NANCY M. ALBERT, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657459
- Sponsor's protocol ID
- 18-442
- Status last verified
- Apr 2025
- First submitted
- 30 Aug 2018
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education
- ClinicalTrials.gov ID
- NCT03657459
- Acronym / sponsor ID
- 18-442
- Conditions
- Heart Failure; With Decompensation
- Keywords
- video education, self care management, symptom recognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Wellflix, Inc.
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.
Detailed description
The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled prospective trial
| Arm | Type | Receives |
|---|---|---|
| usual care group | No intervention | –Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs |
| video education group | Active comparator | Behavioral: Danger Signs of Heart Failure VideosWill receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization,
- Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed,
- Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed,
- Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.
Key exclusion criteria (8 listed)
- Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration),
- Plans to discharge to skilled nursing facility or hospice care,
- Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV HF),
- Hospitalized but at admission, in New York Heart Association functional class I or II HF
- Post-cardiac transplantation or ventricular assist device placement,
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 |
|---|---|---|
| Danger Signs of Heart Failure VideosShort (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors | Behavioural | video education group |
Primary outcome
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Time frame: up to 30 days
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
29 secondary outcomes
Number of Participants With HF-related Hospitalization
Time frame: up to 30 days
Number of Participants With HF-related ED Visits
Time frame: up to 30 days
Number of Participants With HF-related Death
Time frame: up to 30 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Time frame: up to 90 days
Number of Participants With HF-related Hospitalization
Time frame: up to 90 days
Number of Participants With HF-related ED Visit
Time frame: up to 90 days
Number of Participants With HF-related Death
Time frame: up to 90 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Time frame: up to 180 days
Number of Participants With HF-related Hospitalization
Time frame: up to 180 days
Number of Participants With HF-related ED Visit
Time frame: up to 180 days
Number of Participants With HF-related Death
Time frame: up to 180 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Time frame: up to 30 days
Number of Participants With All-cause Hospitalization
Time frame: up to 30 days
Number of Participants With All-cause ED Visits
Time frame: 30 days
Number of Participants With All-cause Death
Time frame: up to 30 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Time frame: up to 90 days
Number of Participants With All-cause Hospitalization
Time frame: up to 90 days
Number of Participants With All-cause ED Visits
Time frame: up to 90 days
Number of Participants With All-cause Death
Time frame: up to 90 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Time frame: up to 180 days
Number of Participants With All-cause Hospitalization
Time frame: up to 180 days
All-cause ED Visits at 180 Days
Time frame: up to 180 days
All-cause Death at 180 Days Post Discharge
Time frame: up to 180 days
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
Time frame: up to 30 days
Dyspnea at 30 Days Post Discharge
Time frame: 30 days
Fatigue at 30 Days Post Discharge
Time frame: to 30 days
Self-efficacy for Managing Symptoms at 30 Days Post Discharge
Time frame: 30 days
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
Time frame: 30 days
Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plans to share individual data
Related trials for Heart Failure; With Decompensation
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
Recruiting
Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Heart Failure; With Decompensation
Recruiting
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Heart Failure, Cardiorenal Syndrome
Recruiting
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
MASLD, Liver Cirrhosis, Alcoholic
Active, not recruitingObservational study
Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
Heart Failure, Heart Failure NYHA Class IV
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.
NANCY M. ALBERT, PhD principal investigator
The Cleveland Clinic
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Danger Signs of Heart Failure Videos in people with Heart Failure; With Decompensation, run by The Cleveland Clinic at 8 sites 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 4 inclusion and 8 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 7 May 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?
Number of Participants With HF-related Healthcare Resource Utilization (HCRU) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.