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

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: Completed
• Conditions: Heart Failure; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Heart Failure Prevention Clinic

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: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	baseline, 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	baseline, 1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence at 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	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	All participants will undergo echocardiogram at baseline and at 1 year.	baseline, 1-year
Biomarker assay	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	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	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	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	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	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	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

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Sadiya Khan, MD, MSc, Northwestern University

Publications and helpful links

General Publications

• Wang 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. Erratum In: Front Cardiovasc Med. 2022 Feb 18;9:844270.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID 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