Clinical trial NCT01942395: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary F2-Isoprostanes
timeFrame: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
Secondary outcomes:
measure: 24-hour ambulatory blood pressure (mean and diurnal variation)
timeFrame: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
measure: Carotid-femoral pulse wave velocity
timeFrame: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
measure: Six minute walk test distance
timeFrame: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
measure: Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product
timeFrame: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
measure: Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)
timeFrame: 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
measure: Knowledge, skills and attitudes related to DASH/SRD
timeFrame: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
measure: Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells
timeFrame: 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
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Scott L Hummel, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.