Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

NCT ID: NCT04684264

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2024-02-01

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.

Conditions

Heart Failure; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pharmacist-directed collaborative practice

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

Group Type: EXPERIMENTAL

Heart Failure Prevention Clinic

Intervention Type: 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.

Usual care

Participants will receive usual care with their primary care physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Sadiya Khan

Assistant Professor of Medicine (Cardiology) and Preventive Medicine (Epidemiology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadiya Khan, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Preventive Medicine

Chicago, Illinois, United States

Countries

United States

References

Wang MC, Dolan B, Huang X, Freaney PM, Freed BH, Vega L, Markoski N, Wainright A, Kane B, Seegmiller LE, Shah SJ, Yancy CW, Neeland IJ, Ning H, Lloyd-Jones DM, Khan SS. Feasibility of the Implementation of Tools for Heart Failure Risk Prediction: A Randomized Controlled Pilot Trial. JACC Adv. 2025 Aug;4(8):102004. doi: 10.1016/j.jacadv.2025.102004. Epub 2025 Jul 14.

Reference Type: DERIVED

PMID: 40664007 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34912869 (View on PubMed)

Other Identifiers

STU00210780

Identifier Type: -

Identifier Source: org_study_id