Effect of DASH Eating Pattern on Heart Failure Outcomes

Heart Failure NYHA Class III Clinical Trial

— DASH HF  

Official title:

Effect of Dietary Approaches to Stop Hypertension Eating Pattern on Cardiometabolic Markers in Advanced Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538990
• Other study ID #: STUDY00005216
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: University of Georgia
• Contact: Elisabeth L Sattler, PhD, BSPharm
• Phone: 706-542-1040
• Email: lilian[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III

Intervention

Other:
• DASH Eating Pattern
The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.

Locations

Country	Name	City	State
United States	University of Georgia Clinical and Translational Research Unit	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase	We will compare the change of the following inflammation marker values 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): interleukin (IL)-1a, IL-1b, IL-6, and tumor necrosis factor alpha (TNF-a).	Baseline, week 3, week 6
Other	Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase	Change in mean hemodynamic marker levels will be calculated by comparing mean values from the calibration (week 1-3) and intervention phase (week 3-6). All patients will be instructed to take daily pulmonary artery pressure home readings for the duration of the study.	week 1-3, week 3-6
Primary	Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase	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).	Baseline, week 3, week 6
Secondary	Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase	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).	Baseline, week 3, week 6