Heart Failure
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALDASH diet
Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications
Sponsors
University of California, Davis
American College of Cardiology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single arm pragmatic trial with pre- and post- assessments
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | Dietary intake at baseline | Dietary intake assessed by nutrient analysis of food records |
| Diet score | Dietary intake at baseline | 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. |
| Blood Pressure | Systolic and diastolic Blood Pressure at baseline | Blood Pressure assessed with systolic and diastolic pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure clinical marker | proBNP at baseline | proBNP will be assessed as a marker of severity of heart failure |
| Patient report of HF symptoms | KCCQ at baseline | Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome. |
| Patient report of eating habit self efficacy | Eating Habits at Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrancene Steinberg, PhD
University of California, Davis
Outcome results
None listed