Clinical trial NCT04684264: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
Official title: Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiovascular Risk Factor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 101
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline in BNP at 1 year
timeFrame: baseline, 1-year
Secondary outcomes:
measure: Change from baseline in hs-cTn at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in BP at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in weight status at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in serum glucose at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in LDL at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in estimated glomerular filtration rate at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in creatinine at 1 year
timeFrame: baseline, 1-year
measure: Smoking quit attempt or cessation
timeFrame: baseline, 1-year
Other outcomes:
measure: Medication adherence at 1 year
timeFrame: 1 year
measure: Change from baseline in E/e' ratio at 1 year
timeFrame: baseline, 1-year
measure: Change from baseline in left ventricular mass index at 1 year
timeFrame: baseline, 1-year
measure: Biomarker assay
timeFrame: baseline
measure: Change from baseline in fruit and vegetable intake
timeFrame: baseline, 1-year
measure: Change from baseline in salt intake
timeFrame: baseline, 1-year
measure: Change from baseline in physical activity
timeFrame: baseline, 1-year
measure: Change from baseline in sedentary behavior
timeFrame: baseline, 1-year
measure: Change from baseline in health utility
timeFrame: baseline, 1-year
measure: Change from baseline in overall health
timeFrame: baseline, 1-year
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Preventive Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Sadiya Khan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.