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Completed

NCT Number: NCT04684264

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Cardiovascular Risk Factor Heart Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Preventive Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Failure Prevention Clinic

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

Acronym: FIT-HF

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 24, 2020
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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