Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

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

Detailed Description
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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.

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

Conditions
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Heart Failure, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Heart Failure Prevention Clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist-directed collaborative practice<br>Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention. | Other: Heart Failure Prevention Clinic<br>* 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.<br>|
| No Intervention: Usual care<br>Participants will receive usual care with their primary care physician. | |

What is the study measuring?
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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 |