Trial record 3 of 67 for:    Open Studies | sodium AND (diet OR dietary)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Scott L. Hummel, University of Michigan
ClinicalTrials.gov Identifier:
NCT01942395
First received: August 21, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Urinary F2-Isoprostanes [ Time Frame: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24-hour ambulatory blood pressure (mean and diurnal variation) [ Time Frame: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14 ] [ Designated as safety issue: No ]
  • Carotid-femoral pulse wave velocity [ Time Frame: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14 ] [ Designated as safety issue: No ]
  • Six minute walk test distance [ Time Frame: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14 ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product [ Time Frame: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14 ] [ Designated as safety issue: Yes ]
  • Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) [ Time Frame: The change from Week 3 in Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) at Week 6, and Week 14 ] [ Designated as safety issue: No ]
  • Knowledge, skills and attitudes related to DASH/SRD [ Time Frame: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6 ] [ Designated as safety issue: No ]
    Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires

  • Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells [ Time Frame: The change from Baseline in Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells at Week 3, Week 6, and Week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DASH/Sodium-Restricted Diet Intervention
Each patient will eat 3 weeks of the provided DASH/SRD diet for 21 days. The diet is patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.
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.
Other Names:
  • DASH diet
  • sodium-restricted diet
  • low sodium diet
  • DASH-sodium
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.
Active Comparator: Control Diet Intervention
Patients will consume 3 weeks of a specially prepared diet that will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants. At enrollment patients will be randomized to the DASH/SRD or Control Diet for 21 days and then cross over to the other for 21 days. Immediately following the provided DASH/SRD and Control Diet, patients will be instructed to adhere to the DASH/SRD for an additional eight weeks with dietary support.
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.
Other Names:
  • DASH diet
  • sodium-restricted diet
  • low sodium diet
  • DASH-sodium
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.
No Intervention: Healthy Control
Fifteen healthy age-matched and 10 young healthy control patients will be recruited. Age-matched healthy control subjects will undergo testing before and after 3 weeks of eating their habitual diet. Young healthy control subjects will only require 1 study visit with no dietary intervention.

Detailed Description:

In an earlier study, the investigators found that patients with HFPEF who ate a special diet for three weeks had improved blood pressure control and lower levels of blood chemicals that may damage the heart and blood vessels. The eating plan in the study was based on the DASH diet, also known as the Dietary Approaches to Stop Hypertension diet. This plan is rich in fruits, vegetables, and low-fat dairy, and is recommended to decrease blood pressure in patients with hypertension. Current medical guidelines also recommend that both patients with hypertension and those with heart failure should decrease their dietary salt intake.

The diets that patients will eat in this study are the DASH/sodium-restricted (DASH/SRD) diet as well as a control diet based on the average reported diet collected using Food Frequency Questionnaires during our pilot study. Patients will be randomized to one diet for three weeks and then crossover to the other diet for three weeks. Patients will then be asked to eat the DASH/sodium-restricted diet on their own at home with dietary support for an additional eight weeks.

In this study, the main goal is to confirm the findings of our earlier study. The investigators would also like to understand how the DASH/SRD changes the function of the heart and blood vessels during exercise and the activity of genes that could be involved in HFPEF.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Symptoms and/or signs of HFPEF in the past 12 months
  • Most recent 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)
  • 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, except diuretic dose adjustment (within past 1 week)
  • Previous LVEF < 40%
  • Primary exercise limitation due to severe pulmonary disease
  • Uninterpretable echocardiographic windows
  • Worse than moderate mitral or aortic stenosis or insufficiency.
  • Baseline serum potassium level > 5.0 mmol/L or prior history of potassium > 6.0
  • Serum calcium/phosphorus product > 50 at baseline
  • Severe renal insufficiency (current estimated GFR < 30 ml/min)
  • Severe anemia (Hgb < 9 g/dL)
  • Severely uncontrolled diabetes mellitus (Hgb A1C > 10%)
  • Non-hypertension related cause of HFPEF (e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes, primary hypertrophic or restrictive cardiomyopathy)
  • Primary right ventricular failure
  • 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
  • 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: NCT01942395

Contacts
Contact: Joanna Wells 734-232-6383 joannamw@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Scott L Hummel, MD MS    734-764-7440    scothumm@med.umich.edu   
Contact: Joanna M Wells    734-232-6383    joannamw@med.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

Additional Information:
Publications:
Responsible Party: Scott L. Hummel, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01942395     History of Changes
Other Study ID Numbers: HUM00052649
Study First Received: August 21, 2013
Last Updated: September 13, 2013
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 ejection fraction

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

ClinicalTrials.gov processed this record on July 22, 2014