Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00939640
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date July 2009
Completion date May 2011

See also
  Status Clinical Trial Phase
Recruiting NCT02499601 - CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) N/A
Completed NCT02537041 - Non-invasive Evaluation of Myocardial Stiffness by Elastography N/A
Completed NCT02275793 - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Withdrawn NCT00773084 - Aliskiren and Renin Inhibition in Diastolic Heart Failure N/A
Terminated NCT00293150 - Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure Phase 4
Terminated NCT01942395 - Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2) N/A
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Terminated NCT01778894 - Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
Completed NCT04154878 - 2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).
Recruiting NCT01599117 - A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF] Phase 3
Completed NCT01185067 - Physiological Effects of Grape Seed Extract in Diastolic Heart Failure Phase 1
Completed NCT03338374 - Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction N/A
Completed NCT02589977 - Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF Phase 4
Completed NCT02147613 - High Intensity Interval Exercise in Diastolic Heart Failure N/A
Terminated NCT00083772 - Use of Nesiritide in the Management of Acute Diastolic Heart Failure Phase 4
Completed NCT00303498 - A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure Phase 2
Terminated NCT02254382 - Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure N/A
Completed NCT00839228 - Perhexiline Therapy in Heart Failure With Preserved Ejection Fraction Syndrome Phase 2
Terminated NCT00662116 - Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I) Phase 2
Completed NCT02084992 - A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure N/A