← Back to Search

Dietary intervention for Heart Failure (DASH-DHF Trial)

N/A
Waitlist Available
Led By Scott L Hummel, MD MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Awards & highlights
No Placebo-Only Group

Summary

Heart failure with preserved systolic function (HF-PSF, or 'diastolic heart failure') accounts for half of hospitalizations for heart failure in patients over the age of 65. Most HF-PSF patients have systemic hypertension (HTN), and characteristic HTN-induced cardiovascular changes contribute to HF-PSF. However, it is unclear why most patients with HTN never develop HF-PSF or which specific aspects of HTN predispose to HF-PSF. In the Dahl S rat, the primary animal model of HF-PSF, high dietary sodium intake suppresses the systemic renin-angiotensin-aldosterone system, but upregulates renal and cardiac renin-angiotensin-aldosterone system by inducing oxidative stress. In humans, the magnitude of blood pressure response to sodium ingestion and depletion can categorize subjects as "salt-resistant" and "salt-sensitive." Human salt sensitivity is associated with structural and loading conditions that increase the risk for HF-PSF, including HTN, ventricular hypertrophy and diastolic dysfunction, arterial stiffening, and increased plasma volume. High dietary sodium intake induces oxidative stress in salt-sensitive humans. In humans with HTN and normal ventricular systolic function that do not have heart failure, increased oxidative stress predicts impaired exercise capacity, ventricular hypertrophy, diastolic dysfunction, arterial stiffening, and vascular endothelial dysfunction. The investigators have proposed that "salt sensitivity" and the accompanying oxidative stress on the typical high-sodium Western diet may contribute to the initiation and progression of HF-PSF. In patients with HF-PSF, the investigators will relate dietary changes to biochemical and cardiovascular functional measures. The investigators will study subjects on ad-lib diet and and following three weeks of rigorous dietary modification with the Dietary Approaches to Stop Hypertension (DASH)/sodium-restricted diet (SRD). This diet is richer in natural antioxidants and lower in sodium than the usual American diet. The DASH/SRD is recommended to lower blood pressure in patients with HTN, and is particularly effective in elderly, obese, and salt-sensitive hypertensives. Dietary sodium restriction is recommended for all HF patients including those with HF-PSF. The investigators hypothesize that the DASH/SRD will have favorable effects on oxidative stress, ventricular and vascular function, and blood pressure control in patients with hypertensive HF-PSF.

Eligible Conditions
  • High blood pressure
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Aortic Augmentation Index
Diurnal Variation in Ambulatory Blood Pressure
Mean 24-hour Systolic Blood Pressure
+1 more
Other study objectives
Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dietary interventionExperimental Treatment1 Intervention
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DASH/sodium-restricted diet (SRD)
2009
N/A
~20

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,857 Previous Clinical Trials
6,437,673 Total Patients Enrolled
26 Trials studying Heart Failure
12,220 Patients Enrolled for Heart Failure
Scott L Hummel, MD MSPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Heart Failure
18 Patients Enrolled for Heart Failure
~1 spots leftby Dec 2025