Clinical trial NCT05117086: DASH Diet in Heart Failure Outpatients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: American College of Cardiology
First posted: 2021-11-11
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pragmatic trial with pre- and post- assessments
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dietary intake
timeFrame: Dietary intake at baseline
measure: Dietary intake
timeFrame: Dietary intake at 3 months
measure: Dietary intake
timeFrame: Dietary intake at 6 months
measure: Diet score
timeFrame: Dietary intake at baseline
measure: Diet score
timeFrame: Dietary intake at 3 months
measure: Diet score
timeFrame: Dietary intake at 6 months
measure: Blood Pressure
timeFrame: Systolic and diastolic Blood Pressure at baseline
measure: Blood Pressure
timeFrame: Systolic and diastolic Blood Pressure at 3 months
measure: Blood Pressure
timeFrame: Systolic and diastolic Blood Pressure at 6 months
Secondary outcomes:
measure: Heart Failure clinical marker
timeFrame: proBNP at baseline
measure: Heart Failure clinical marker
timeFrame: proBNP at 3 months
measure: Heart Failure clinical marker
timeFrame: proBNP at 6 months
measure: Patient report of HF symptoms
timeFrame: KCCQ at baseline
measure: Patient report of HF symptoms
timeFrame: KCCQ at 3 months
measure: Patient report of HF symptoms
timeFrame: KCCQ at 6 months
measure: Patient report of eating habit self efficacy
timeFrame: Eating Habits at Baseline
measure: Patient report of eating habit self efficacy
timeFrame: Eating Habits at 3 months
measure: Patient report of eating habit self efficacy
timeFrame: Eating Habits at 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health Center - Cardiology Department
state: California
Study officials:
affiliation: University of California, Davis
name: Francene Steinberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: