DASH Diet in Heart Failure Outpatients

Heart Failure Clinical Trial

— DASH-HF  

Official title:

DASH Diet in Heart Failure Pilot Study - Integration and Effectiveness of Medical Nutrition Therapy Counseling on DASH Diet in the Management of Heart Failure Patients in an Academic Outpatient Cardiology Clinic

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05117086
• Other study ID #: 1770356
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

Description:

The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Heart Failure diagnosis
• Guideline directed medical therapy optimization on stable regimen at least 30 days

Exclusion Criteria:

• BMI < 18/5 kg/m squared
• cardiac cachexia
• end-stage renal disease or dialysis
• acute inflammatory condition
• uncontrolled arrhythmias or ischemia
• status post heart transplant or implanted left ventricular assist device

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• DASH diet
Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications

Locations

Country	Name	City	State
United States	UC Davis Health Center - Cardiology Department	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	American College of Cardiology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at baseline
Primary	Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at 3 months
Primary	Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at 6 months
Primary	Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at baseline
Primary	Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at 3 months
Primary	Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at 6 months
Primary	Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at baseline
Primary	Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at 3 months
Primary	Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at 6 months
Secondary	Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at baseline
Secondary	Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at 3 months
Secondary	Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at 6 months
Secondary	Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at baseline
Secondary	Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at 3 months
Secondary	Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at 6 months
Secondary	Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at Baseline
Secondary	Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at 3 months
Secondary	Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at 6 months