Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure (DASH-DHF)

October 13, 2019 updated by: Scott L. Hummel, University of Michigan

Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet on Ventriculovascular Function in Heart Failure With Preserved Systolic Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Satisfy European Society of Cardiology guidelines for the diagnosis of HF-PSF (Paulus WJ et al. Eur. Heart J. 2007;28:2539-2550).
  • Framingham criteria for heart failure satisfied
  • left ventricular ejection fraction ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy)
  • Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml) with supporting evidence (atrial fibrillation, left atrial enlargement, left ventricular hypertrophy)
  • History of systemic hypertension
  • Willing to adhere to provided diet

Exclusion Criteria:

  • New York Heart Association Class IV heart failure symptoms
  • Hospitalization for decompensated heart failure within past one month
  • Uncontrolled hypertension (seated systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110) at rest, on current antihypertensive regimen
  • Changes in medical regimen for heart disease or hypertension within past 1 month, including diuretic dose adjustment
  • Primary exercise limitation due to severe pulmonary disease
  • Poor echocardiographic windows
  • Worse than moderate mitral or aortic stenosis or insufficiency.
  • Serum potassium level > 5.0 mmol/L at baseline or prior history of serum potassium level > 6.0
  • Serum calcium/phosphorus product > 50 at baseline
  • Severe renal insufficiency (current estimated glomerular filtration rate < 30 ml/min)
  • Severe anemia (hemoglobin < 9 g/dL)
  • Uncontrolled diabetes mellitus (hemoglobin A1c > 9%)
  • Non-hypertensive cause of HF-PSF, e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes
  • Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months
  • Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation)
  • Terminal illness expected to result in death within six months or active solid-organ cancer
  • Psychiatric disorder or dementia with potential to compromise dietary adherence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary 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.
Behavioral: DASH/sodium-restricted diet (SRD)
Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
Other Names:
  • DASH diet
  • sodium-restricted diet
  • low sodium diet
  • DASH-sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brachial Artery Flow-mediated Dilation (FMD)
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean 24-hour Systolic Blood Pressure
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Change in 24-hour systolic blood pressure
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Diurnal Variation in Ambulatory Blood Pressure
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Aortic Augmentation Index
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease.
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Carotid-femoral Pulse Wave Velocity
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Ventricular Diastolic Function
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Lateral mitral annulus E/e' ratio
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Six Minute Walk Test Distance
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Urinary 8-isoprostanes
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EndoPAT Arterial Endothelial Function
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product
Time Frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Safety measures to determine adverse effects of the provided DASH diet home-delivered meals
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Scott L Hummel, MD MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 13, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00025253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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