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

Northwestern University

Status: Completed

Conditions: Heart Failure; Cardiovascular Risk Factor

Treatments: Other: Heart Failure Prevention Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT04684264

STU00210780

Details and patient eligibility

About

The purpose of this study is to gather information to develop a heart failure screening and prevention program.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Pharmacist-directed collaborative practice

Experimental group

Description:

Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention.

Treatment:

Other: Heart Failure Prevention Clinic

Usual care

No Intervention group

Description:

Participants will receive usual care with their primary care physician.