Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF)

March 18, 2024 updated by: Sadiya Khan, Northwestern University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pharmacist-directed collaborative practice
Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention.
Other: Heart Failure Prevention Clinic
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.
No Intervention: Usual care
Participants will receive usual care with their primary care physician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 1-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in hs-cTn at 1 year
Time Frame: baseline, 1-year
All participants will have high sensitivity cardiac troponin (hs-cTn) measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in BP at 1 year
Time Frame: baseline, 1-year
All participants will have systolic blood pressure and diastolic blood pressure measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in weight status at 1 year
Time Frame: baseline, 1-year
All participants will have weight and BMI measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in serum glucose at 1 year
Time Frame: baseline, 1-year
All participants will have serum glucose measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in LDL at 1 year
Time Frame: baseline, 1-year
All participants will have LDL cholesterol measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in estimated glomerular filtration rate at 1 year
Time Frame: baseline, 1-year
All participants will have estimated glomerular filtration rate measured at baseline and at 1-year follow-up.
baseline, 1-year
Change from baseline in creatinine at 1 year
Time Frame: baseline, 1-year
All participants will have creatinine measured at baseline and at 1-year follow-up.
baseline, 1-year
Smoking quit attempt or cessation
Time Frame: baseline, 1-year
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.
baseline, 1-year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication adherence at 1 year
Time Frame: 1 year
All participants will be asked about adherence to medications (if applicable) using questions of nonadherence from the Atherosclerosis Risk in Communities study.
1 year
Change from baseline in E/e' ratio at 1 year
Time Frame: baseline, 1-year
All participants will undergo echocardiogram at baseline and at 1 year.
baseline, 1-year
Change from baseline in left ventricular mass index at 1 year
Time Frame: baseline, 1-year
All participants will undergo echocardiogram at baseline and at 1 year.
baseline, 1-year
Biomarker assay
Time Frame: baseline
All participants will have biorepository storage of serum and plasma at baseline. An exploratory analysis will use a commercial biomarker array to investigate correlations with echocardiogram, BNP, and hs-cTn results.
baseline
Change from baseline in fruit and vegetable intake
Time Frame: baseline, 1-year
All participants will be asked about fruit and vegetable intake at baseline and at 1 year. Outcome will be measured in servings/week.
baseline, 1-year
Change from baseline in salt intake
Time Frame: baseline, 1-year
All participants will be asked about salt intake at baseline and at 1 year using a 5-point Likert scale (always, often, sometimes, rarely, never). A higher score on this scale is preferable.
baseline, 1-year
Change from baseline in physical activity
Time Frame: baseline, 1-year
All participants will be asked about physical activity at baseline and at 1 year. Outcome is measured in minutes of moderate-intensity activity per week. Vigorous-intensity activity will count as twice the equivalent duration of moderate-intensity activity.
baseline, 1-year
Change from baseline in sedentary behavior
Time Frame: baseline, 1-year
All participants will be asked about sedentary behavior at baseline and at 1 year. Outcome is measured in minutes of sedentary behavior per day.
baseline, 1-year
Change from baseline in health utility
Time Frame: baseline, 1-year
Health utility will be measured by the EurolQol 5 Dimensions 5 Levels (EQ-5D-5L) instrument. Typical scores range from 0 to 1, with 1 being ideal health-related quality of life.
baseline, 1-year
Change from baseline in overall health
Time Frame: baseline, 1-year
Overall health will be measured by the EurolQol Visual Analog Scale (EQ VAS) instrument. Scores range from 0-100, with 100 being the highest overall health.
baseline, 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sadiya Khan, MD, MSc, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00210780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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