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NCT00939640 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
14
Enrollment target

NCT00939640 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 14 participants.

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The verdict

NCT00939640, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
14 participants
Enrollment target

Study 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 A

Interventions

  • BEHAVIORAL DASH/sodium-restricted diet (SRD)

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2009-07
Est. Completion 2011-05
Phase NA

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT00939640

The ClinicalTrials.gov registry entry for NCT00939640 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which DASH/sodium-restricted diet (SRD) is the first listed.

NCT00939640 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00939640 about?

NCT00939640 is a clinical study titled "Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure". 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-...

What is the current status of trial NCT00939640?

This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2009-07. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00939640?

The interventions under investigation include: DASH/sodium-restricted diet (SRD) (BEHAVIORAL).

Who is sponsoring clinical trial NCT00939640?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.