Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

Heart Failure Clinical Trial

— FIT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684264
• Other study ID #: STU00210780
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 1, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University Department of Preventive Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change from baseline in E/e' ratio at 1 year	All participants will undergo echocardiogram at baseline and at 1 year.	baseline, 1-year
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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