Effect of DASH Eating Pattern on Heart Failure Outcomes

Not Applicable

• Conditions: Heart Failure NYHA Class III

• Registration Number: NCT03538990
• Lead Sponsor: University of Georgia

Brief Summary

The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-29
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Study Start: 2018-11-15
• Last Update Posted: 2018-11-16
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. 18+ years of age
2. English language literacy
3. Diagnosis of HF ≥ 3 months
4. Diagnosis of NYHA Class III HF (historical assessment)
5. Subjects must be stable on HF medication regimen for one month prior to study entry
6. At least 1 HF hospitalization within 24 months of enrollment
7. BNP >200 pg/ml

Exclusion Criteria

1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment
2. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis
3. Subjects likely to undergo heart transplantation within 2 months of enrollment
4. Subjects with severe conditions limiting 6-month survival
5. Unavailability during scheduled data collection points
6. Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase	Baseline, week 3, week 6	Change of the following cardiometabolic marker values will be calculated between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention): fasting lipid panel, hemoglobin A1c, basic metabolic panel (sodium, potassium, chloride, carbon dioxide (CO2), blood urea nitrogen, creatinine, and glucose), B-type natriuretic peptide (BNP), N terminal proBNP, troponin 1, mid-regional pro-adrenomedullin (MR-proADM), soluble somatostatin receptor 2 (sST2).

Secondary Outcome Measures

Name	Time	Method
Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase	Baseline, week 3, week 6	We will compare the change in functional exercise capacity using the American Thoracic Society 6-minute walk test between calibration and intervention phase using repeated measures analysis methods (3 time points over the course of 6 weeks: baseline, mid-point, post-DASH intervention).

Trial Locations

Locations (1)

University of Georgia Clinical and Translational Research Unit; 🇺🇸 Athens, Georgia, United States