Cardiovascular Risk Factor, Heart Failure
Conditions
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.
Interventions
OTHERHeart 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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BNP at 1 year | baseline, 1-year | All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BP at 1 year | baseline, 1-year | All participants will have systolic blood pressure and diastolic blood pressure measured at baseline and at 1-year follow-up. |
| Change from baseline in weight status at 1 year | baseline, 1-year | All participants will have weight and BMI measured at baseline and at 1-year follow-up. |
| Change from baseline in serum glucose at 1 year | baseline, 1-year | All participants will have serum glucose measured at baseline and at 1-year follow-up. |
| Change from baseline in hs-cTn at 1 year | baseline, 1-year | All participants will have high sensitivity cardiac troponin (hs-cTn) measured at baseline and at 1-year follow-up. |
| Change from baseline in estimated glomerular filtration rate at 1 year | baseline, 1-year | All participants will have estimated glomerular filtration rate measured at baseline and at 1-year follow-up. |
| Change from baseline in creatinine at 1 year | baseline, 1-year | All participants will have creatinine measured at baseline and at 1-year follow-up. |
| Smoking quit attempt or cessation | baseline, 1-year | 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. |
| Change from baseline in LDL at 1 year | baseline, 1-year | All participants will have LDL cholesterol measured at baseline and at 1-year follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence at 1 year | 1 year | All participants will be asked about adherence to medications (if applicable) using questions of nonadherence from the Atherosclerosis Risk in Communities study. |
| Change from baseline in overall health | baseline, 1-year | 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. |
| Change from baseline in E/e' ratio at 1 year | baseline, 1-year | All participants will undergo echocardiogram at baseline and at 1 year. |
| Change from baseline in left ventricular mass index at 1 year | baseline, 1-year | All participants will undergo echocardiogram at baseline and at 1 year. |
| Biomarker assay | baseline | 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. |
| Change from baseline in fruit and vegetable intake | baseline, 1-year | All participants will be asked about fruit and vegetable intake at baseline and at 1 year. Outcome will be measured in servings/week. |
| Change from baseline in salt intake | baseline, 1-year | 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. |
| Change from baseline in physical activity | baseline, 1-year | 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. |
| Change from baseline in sedentary behavior | baseline, 1-year | All participants will be asked about sedentary behavior at baseline and at 1 year. Outcome is measured in minutes of sedentary behavior per day. |
| Change from baseline in health utility | baseline, 1-year | 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. |
Countries
United States
Outcome results
None listed