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

Primary Purpose

Diastolic Heart Failure, Hypertensive Heart Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DASH/sodium-restricted diet (DASH/SRD)

Control Diet

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Diet, Sodium, Hypertension, Potassium, Antioxidants, Congestive Heart Failure, Heart failure with normal ejection fraction, Heart failure with preserved ejection fraction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

DASH/Sodium-Restricted Diet Intervention

Control Diet Intervention

Healthy Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Urinary F2-Isoprostanes

Secondary Outcome Measures

24-hour ambulatory blood pressure (mean and diurnal variation)

Carotid-femoral pulse wave velocity

Six minute walk test distance

Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product

Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)

Knowledge, skills and attitudes related to DASH/SRD

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

Full Information

NCT ID

NCT01942395

First Posted

August 21, 2013

Last Updated

June 4, 2018

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01942395

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

study diet is no longer available to match with the previous participants.

Study Start Date

September 18, 2012 (Actual)

Primary Completion Date

November 18, 2015 (Actual)

Study Completion Date

February 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diastolic Heart Failure, Hypertensive Heart Disease

Keywords

Diet, Sodium, Hypertension, Potassium, Antioxidants, Congestive Heart Failure, Heart failure with normal ejection fraction, Heart failure with preserved ejection fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DASH/Sodium-Restricted Diet Intervention

Arm Type

Active Comparator

Arm Description

Arm Title

Control Diet Intervention

Arm Type

Active Comparator

Arm Description

Arm Title

Healthy Control

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

DASH/sodium-restricted diet (DASH/SRD)

Other Intervention Name(s)

DASH diet, sodium-restricted diet, low sodium diet, DASH-sodium

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control Diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urinary F2-Isoprostanes

Time Frame

The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14

Secondary Outcome Measure Information:

Title

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

Title

Carotid-femoral pulse wave velocity

Time Frame

The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14

Title

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

Title

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

Title

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

Title

Knowledge, skills and attitudes related to DASH/SRD

Description

Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires

Time Frame

Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott L Hummel, MD MS

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16855265

Citation

Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

Results Reference

background

PubMed Identifier

23033371

Citation

Hummel SL, Seymour EM, Brook RD, Kolias TJ, Sheth SS, Rosenblum HR, Wells JM, Weder AB. Low-sodium dietary approaches to stop hypertension diet reduces blood pressure, arterial stiffness, and oxidative stress in hypertensive heart failure with preserved ejection fraction. Hypertension. 2012 Nov;60(5):1200-6. doi: 10.1161/HYPERTENSIONAHA.112.202705. Epub 2012 Oct 1.

Results Reference

background

PubMed Identifier

19404315

Citation

Al-Solaiman Y, Jesri A, Zhao Y, Morrow JD, Egan BM. Low-Sodium DASH reduces oxidative stress and improves vascular function in salt-sensitive humans. J Hum Hypertens. 2009 Dec;23(12):826-35. doi: 10.1038/jhh.2009.32. Epub 2009 Apr 30.

Results Reference

background

PubMed Identifier

20813282

Citation

Borlaug BA, Olson TP, Lam CS, Flood KS, Lerman A, Johnson BD, Redfield MM. Global cardiovascular reserve dysfunction in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2010 Sep 7;56(11):845-54. doi: 10.1016/j.jacc.2010.03.077.

Results Reference

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Links:

URL

https://www.umms.med.umich.edu/umclinicalstudies/detail_pub_study.do

Description

Research study posting at: UMClinicalStudies.org

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

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