Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Heart Failure
• Interventions: Other: Heart Failure Prevention Clinic

• Registration Number: NCT04684264
• Lead Sponsor: Northwestern University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Study Start: 2021-03-03
• Primary Completion: 2023-08-30
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-directed collaborative practice	Heart Failure Prevention Clinic	Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention.

Primary Outcome Measures

Name	Time	Method
Change from baseline in BNP at 1 year	baseline, 1-year	All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in hs-cTn at 1 year	baseline, 1-year	All participants will have high sensitivity cardiac troponin (hs-cTn) measured at baseline and at 1-year follow-up.
Change from baseline in BP at 1 year	baseline, 1-year	All participants will have systolic blood pressure and diastolic blood pressure measured at baseline and at 1-year follow-up.
Change from baseline in serum glucose at 1 year	baseline, 1-year	All participants will have serum glucose measured at baseline and at 1-year follow-up.
Change from baseline in weight status at 1 year	baseline, 1-year	All participants will have weight and BMI measured at baseline and at 1-year follow-up.
Change from baseline in creatinine at 1 year	baseline, 1-year	All participants will have creatinine measured at baseline and at 1-year follow-up.
Change from baseline in LDL at 1 year	baseline, 1-year	All participants will have LDL cholesterol measured at baseline and at 1-year follow-up.
Change from baseline in estimated glomerular filtration rate at 1 year	baseline, 1-year	All participants will have estimated glomerular filtration rate measured at baseline and at 1-year follow-up.
Smoking quit attempt or cessation	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.

Trial Locations

Locations (1)

Northwestern University Department of Preventive Medicine; 🇺🇸 Chicago, Illinois, United States