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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00939640
First received: July 14, 2009
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Diastolic Heart Failure
Hypertensive Heart Disease
Behavioral: DASH/sodium-restricted diet (SRD)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet on Ventriculovascular Function in Heart Failure With Preserved Systolic Function

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation (FMD) [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean 24-hour blood pressure [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Diurnal variation in ambulatory blood pressure [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Aortic augmentation index [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • EndoPAT arterial endothelial function [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Carotid-femoral pulse wave velocity [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Ventricular diastolic function [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Six minute walk test distance [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: Yes ]
  • Urinary 8-isoprostanes [ Time Frame: Pre- and post three weeks of dietary intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 HF satisfied
  • LVEF ≥ 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:

  • NYHA Class IV heart failure symptoms
  • Hospitalization for decompensated HF within past one month
  • Uncontrolled hypertension (seated SBP ≥ 180 or DBP ≥ 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 GFR < 30 ml/min)
  • Severe anemia (Hgb < 9 g/dL)
  • Uncontrolled diabetes mellitus (Hgb A1C > 9%)
  • Non-hypertensive cause of HFPSF, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939640

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Scott L Hummel, MD MS    734-936-5265    scothumm@med.umich.edu   
Contact: Joanna M Wells    734 232 6383    joannamw@umich.edu   
Principal Investigator: Scott L Hummel, MD MS         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Scott L Hummel, MD MS University of Michigan
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott L. Hummel MD MS, University of Michigan
ClinicalTrials.gov Identifier: NCT00939640     History of Changes
Other Study ID Numbers: HUM00025253
Study First Received: July 14, 2009
Last Updated: September 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Diet
Sodium
Hypertension
Potassium
Antioxidants
congestive heart failure
Heart failure with normal ejection fraction
Heart failure with preserved systolic function

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Heart Failure, Diastolic
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014