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Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)

NCT01942395 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-06

No results posted yet for this study

Summary

The purpose of this study is to examine how dietary changes affect the heart and blood vessels in patients with hypertension (high blod pressure) who have a condition called 'heart failure with preserved ejection fraction" (HFPEF). This condition is also known as "diastolic heart failure" or "heart failure with normal ejection fraction", and occurs even though the heart's pumping function is normal.

Conditions

  • Diastolic Heart Failure
  • Hypertensive Heart Disease

Interventions

BEHAVIORAL

DASH/sodium-restricted diet (DASH/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. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.

BEHAVIORAL

Control Diet

The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.

Sponsors & Collaborators

Principal Investigators

  • Scott L Hummel, MD MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-18
Primary Completion
2015-11-18
Completion
2016-02-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942395 on ClinicalTrials.gov