Heart FailureFIT-HFNCT04684264
Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
A study testing Heart Failure Prevention Clinic in people with Heart Failure and Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to gather information to develop a heart failure screening and prevention program. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Heart Failure, Cardiovascular Risk Factor
- What is being tested?
- Heart Failure Prevention Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 10-year risk of heart failure >5% based on the PCP-HF equations
- At least one primary care visit in the last 12 months
- At least one additional primary care visit in the last 5 years
- Had cholesterol and glucose checked within the past 5 years
Who cannot join
- History of cardiovascular disease
- Signs and symptoms of heart failure
- Estimated glomerular filtration rate <45 mL/min/1.73m^2
- Stage 3 or 4 cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Preventive Medicine
Chicago, Illinois, 60611
About this study
Official title: Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
The purpose of this study is to gather information to develop a heart failure screening and prevention program.
Read the detailed description
All participants will undergo phlebotomy for specimen collection (BNP, hs-cTn, BMP and lipid testing, biorepository storage) and baseline echocardiography. All participants will additionally be administered a health and lifestyle questionnaire, undergo measurement of vital signs, and receive uniform education on heart-healthy lifestyle and signs and symptoms of heart failure. Participants who are randomized to the intervention arm will receive a referral to Heart Failure Prevention Clinic, a pharmacist-directed practice in collaboration with an attending cardiologist, where they will be followed for 1 year, with their primary care physician updated after each visit. The information from their BNP, hs-cTn, and echocardiography will be provided to them and their primary care physicians as well as the pharmacist and cardiologist team members. The participants (and their primary care providers) who are randomized to usual care will be blinded to their BNP and hs-cTn values and echocardiography results.
- Conditions
- Heart Failure, Cardiovascular Risk Factor
- Being tested
- Heart Failure Prevention Clinic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Prevention ClinicOther
Heart Failure Prevention Clinic is a pharmacist-directed practice in collaboration with an attending cardiologist that uses evidence-based guidelines to optimize medications and lifestyle interventions for heart failure prevention.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-directed collaborative practice | Experimental | Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention. Receives: Other: Heart Failure Prevention Clinic |
| Usual care | No intervention | Participants will receive usual care with their primary care physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BNP at 1 year
All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Secondary outcomes (8)
Change from baseline in hs-cTn at 1 year
All participants will have high sensitivity cardiac troponin (hs-cTn) measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in BP at 1 year
All participants will have systolic blood pressure and diastolic blood pressure measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in weight status at 1 year
All participants will have weight and BMI measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in serum glucose at 1 year
All participants will have serum glucose measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in LDL at 1 year
All participants will have LDL cholesterol measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in estimated glomerular filtration rate at 1 year
All participants will have estimated glomerular filtration rate measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Change from baseline in creatinine at 1 year
All participants will have creatinine measured at baseline and at 1-year follow-up.
Measured: baseline, 1-year
Smoking quit attempt or cessation
All participants will be asked about smoking status at baseline and at 1-year follow-up. Outcome is, among patients who were current smokers at baseline, quit attempt or no smoking at 1 year.
Measured: baseline, 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start3 Mar 2021
- Primary completion30 Aug 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Northwestern 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiya Khan, Northwestern University
- Investigators
- Sadiya Khan, MD, MSc, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684264
- Sponsor's protocol ID
- STU00210780
- Acronym
- FIT-HF
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang MC, Dolan B, Huang X, Freaney PM, Freed BH, Vega L, Markoski N, Wainright A, Kane B, Seegmiller LE, Shah SJ, Yancy CW, Neeland IJ, Ning H, Lloyd-Jones DM, Khan SS. Feasibility of the Implementation of Tools for Heart Failure Risk Prediction: A Randomized Controlled Pilot Trial. JACC Adv. 2025 Aug;4(8):102004. doi: 10.1016/j.jacadv.2025.102004. Epub 2025 Jul 14.
PubMed 40664007Wang MC, Dolan B, Freed BH, Vega L, Markoski N, Wainright AE, Kane B, Seegmiller LE, Harrington K, Lewis AA, Shah SJ, Yancy CW, Neeland IJ, Ning H, Lloyd-Jones DM, Khan SS. Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study. Front Cardiovasc Med. 2021 Nov 29;8:785109. doi: 10.3389/fcvm.2021.785109. eCollection 2021.
PubMed 34912869
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
- ClinicalTrials.gov ID
- NCT04684264
- Acronym / sponsor ID
- FIT-HF / STU00210780
- Conditions
- Heart Failure, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information to develop a heart failure screening and prevention program.
Detailed description
All participants will undergo phlebotomy for specimen collection (BNP, hs-cTn, BMP and lipid testing, biorepository storage) and baseline echocardiography. All participants will additionally be administered a health and lifestyle questionnaire, undergo measurement of vital signs, and receive uniform education on heart-healthy lifestyle and signs and symptoms of heart failure. Participants who are randomized to the intervention arm will receive a referral to Heart Failure Prevention Clinic, a pharmacist-directed practice in collaboration with an attending cardiologist, where they will be followed for 1 year, with their primary care physician updated after each visit. The information from their BNP, hs-cTn, and echocardiography will be provided to them and their primary care physicians as well as the pharmacist and cardiologist team members. The participants (and their primary care providers) who are randomized to usual care will be blinded to their BNP and hs-cTn values and echocardiography results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-directed collaborative practice | Experimental | Other: Heart Failure Prevention ClinicParticipants will be referred to a pharmacist-directed collaborative practice for heart failure prevention. |
| Usual care | No intervention | –Participants will receive usual care with their primary care physician. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 10-year risk of heart failure >5% based on the PCP-HF equations
- At least one primary care visit in the last 12 months
- At least one additional primary care visit in the last 5 years
- Had cholesterol and glucose checked within the past 5 years
Key exclusion criteria (5 listed)
- History of cardiovascular disease
- Signs and symptoms of heart failure
- Estimated glomerular filtration rate <45 mL/min/1.73m^2
- Stage 3 or 4 cancer
- Pregnancy
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 |
|---|---|---|
| Heart Failure Prevention ClinicHeart Failure Prevention Clinic is a pharmacist-directed practice in collaboration with an attending cardiologist that uses evidence-based guidelines to optimize medications and lifestyle interventions for heart failure prevention. | Other | Pharmacist-directed collaborative practice |
Primary outcome
Change from baseline in BNP at 1 year
Time frame: baseline, 1-year
All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up.
8 secondary outcomes
Change from baseline in hs-cTn at 1 year
Time frame: baseline, 1-year
Change from baseline in BP at 1 year
Time frame: baseline, 1-year
Change from baseline in weight status at 1 year
Time frame: baseline, 1-year
Change from baseline in serum glucose at 1 year
Time frame: baseline, 1-year
Change from baseline in LDL at 1 year
Time frame: baseline, 1-year
Change from baseline in estimated glomerular filtration rate at 1 year
Time frame: baseline, 1-year
Change from baseline in creatinine at 1 year
Time frame: baseline, 1-year
Smoking quit attempt or cessation
Time frame: baseline, 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 40664007Wang MC, Dolan B, Huang X, Freaney PM, Freed BH, Vega L, Markoski N, Wainright A, Kane B, Seegmiller LE, Shah SJ, Yancy CW, Neeland IJ, Ning H, Lloyd-Jones DM, Khan SS. Feasibility of the Implementation of Tools for Heart Failure Risk Prediction: A Randomized Controlled Pilot Trial. JACC Adv. 2025 Aug;4(8):102004. doi: 10.1016/j.jacadv.2025.102004. Epub 2025 Jul 14.
- Derived from this study: PubMed 34912869Wang MC, Dolan B, Freed BH, Vega L, Markoski N, Wainright AE, Kane B, Seegmiller LE, Harrington K, Lewis AA, Shah SJ, Yancy CW, Neeland IJ, Ning H, Lloyd-Jones DM, Khan SS. Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study. Front Cardiovasc Med. 2021 Nov 29;8:785109. doi: 10.3389/fcvm.2021.785109. eCollection 2021.
- 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.
Sadiya Khan, MD, MSc principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure Prevention Clinic in people with Heart Failure and Cardiovascular Risk Factor, run by Northwestern 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 4 inclusion and 5 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 20 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in BNP at 1 year (time frame: baseline, 1-year). 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 NCT04684264, which also lists 2 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 20 Mar 2024.