search
Back to results

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

Primary Purpose

Diastolic Heart Failure, Hypertensive Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH/sodium-restricted diet (SRD)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

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 systolic function

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Satisfy European Society of Cardiology guidelines for the diagnosis of HF-PSF (Paulus WJ et al. Eur. Heart J. 2007;28:2539-2550).
  • Framingham criteria for heart failure satisfied
  • left ventricular ejection fraction ≥ 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) with supporting evidence (atrial fibrillation, left atrial enlargement, left ventricular hypertrophy)
  • History of systemic hypertension
  • Willing to adhere to provided diet

Exclusion Criteria:

  • New York Heart Association Class IV heart failure symptoms
  • Hospitalization for decompensated heart failure within past one month
  • Uncontrolled hypertension (seated systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110) at rest, on current antihypertensive regimen
  • Changes in medical regimen for heart disease or hypertension within past 1 month, including diuretic dose adjustment
  • Primary exercise limitation due to severe pulmonary disease
  • Poor echocardiographic windows
  • Worse than moderate mitral or aortic stenosis or insufficiency.
  • Serum potassium level > 5.0 mmol/L at baseline or prior history of serum potassium level > 6.0
  • Serum calcium/phosphorus product > 50 at baseline
  • Severe renal insufficiency (current estimated glomerular filtration rate < 30 ml/min)
  • Severe anemia (hemoglobin < 9 g/dL)
  • Uncontrolled diabetes mellitus (hemoglobin A1c > 9%)
  • Non-hypertensive cause of HF-PSF, e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes
  • 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 or active solid-organ cancer
  • Psychiatric disorder or dementia with potential to compromise dietary adherence

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary intervention

Arm Description

Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.

Outcomes

Primary Outcome Measures

Brachial Artery Flow-mediated Dilation (FMD)

Secondary Outcome Measures

Mean 24-hour Systolic Blood Pressure
Change in 24-hour systolic blood pressure
Diurnal Variation in Ambulatory Blood Pressure
Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9
Aortic Augmentation Index
Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease.
Carotid-femoral Pulse Wave Velocity
Ventricular Diastolic Function
Lateral mitral annulus E/e' ratio
Six Minute Walk Test Distance
Urinary 8-isoprostanes

Full Information

First Posted
July 14, 2009
Last Updated
October 13, 2019
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT00939640
Brief Title
Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure
Acronym
DASH-DHF
Official Title
Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet on Ventriculovascular Function in Heart Failure With Preserved Systolic Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 American diet. The DASH/SRD is recommended to lower blood pressure in patients with HTN, and is particularly effective in elderly, obese, and salt-sensitive hypertensives. Dietary sodium restriction is recommended for all HF patients including those with HF-PSF. The investigators hypothesize that the DASH/SRD will have favorable effects on oxidative stress, ventricular and vascular function, and blood pressure control in patients with hypertensive HF-PSF.

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 systolic function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention
Arm Type
Experimental
Arm Description
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
Intervention Type
Behavioral
Intervention Name(s)
DASH/sodium-restricted diet (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. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
Primary Outcome Measure Information:
Title
Brachial Artery Flow-mediated Dilation (FMD)
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary Outcome Measure Information:
Title
Mean 24-hour Systolic Blood Pressure
Description
Change in 24-hour systolic blood pressure
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Diurnal Variation in Ambulatory Blood Pressure
Description
Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Aortic Augmentation Index
Description
Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease.
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Carotid-femoral Pulse Wave Velocity
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Ventricular Diastolic Function
Description
Lateral mitral annulus E/e' ratio
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Six Minute Walk Test Distance
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Urinary 8-isoprostanes
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Other Pre-specified Outcome Measures:
Title
EndoPAT Arterial Endothelial Function
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Title
Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product
Description
Safety measures to determine adverse effects of the provided DASH diet home-delivered meals
Time Frame
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Satisfy European Society of Cardiology guidelines for the diagnosis of HF-PSF (Paulus WJ et al. Eur. Heart J. 2007;28:2539-2550). Framingham criteria for heart failure satisfied left ventricular ejection fraction ≥ 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) with supporting evidence (atrial fibrillation, left atrial enlargement, left ventricular hypertrophy) History of systemic hypertension Willing to adhere to provided diet Exclusion Criteria: New York Heart Association Class IV heart failure symptoms Hospitalization for decompensated heart failure within past one month Uncontrolled hypertension (seated systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110) at rest, on current antihypertensive regimen Changes in medical regimen for heart disease or hypertension within past 1 month, including diuretic dose adjustment Primary exercise limitation due to severe pulmonary disease Poor echocardiographic windows Worse than moderate mitral or aortic stenosis or insufficiency. Serum potassium level > 5.0 mmol/L at baseline or prior history of serum potassium level > 6.0 Serum calcium/phosphorus product > 50 at baseline Severe renal insufficiency (current estimated glomerular filtration rate < 30 ml/min) Severe anemia (hemoglobin < 9 g/dL) Uncontrolled diabetes mellitus (hemoglobin A1c > 9%) Non-hypertensive cause of HF-PSF, e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes 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 or active solid-organ cancer 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
12517230
Citation
Redfield MM, Jacobsen SJ, Burnett JC Jr, Mahoney DW, Bailey KR, Rodeheffer RJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA. 2003 Jan 8;289(2):194-202. doi: 10.1001/jama.289.2.194.
Results Reference
background
PubMed Identifier
16585423
Citation
Klotz S, Hay I, Zhang G, Maurer M, Wang J, Burkhoff D. Development of heart failure in chronic hypertensive Dahl rats: focus on heart failure with preserved ejection fraction. Hypertension. 2006 May;47(5):901-11. doi: 10.1161/01.HYP.0000215579.81408.8e. Epub 2006 Apr 3.
Results Reference
background
PubMed Identifier
16432053
Citation
Laffer CL, Bolterman RJ, Romero JC, Elijovich F. Effect of salt on isoprostanes in salt-sensitive essential hypertension. Hypertension. 2006 Mar;47(3):434-40. doi: 10.1161/01.HYP.0000202480.06735.82. Epub 2006 Jan 23.
Results Reference
background
PubMed Identifier
17003543
Citation
Dekleva M, Celic V, Kostic N, Pencic B, Ivanovic AM, Caparevic Z. Left ventricular diastolic dysfunction is related to oxidative stress and exercise capacity in hypertensive patients with preserved systolic function. Cardiology. 2007;108(1):62-70. doi: 10.1159/000095883. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
16247215
Citation
Yugar-Toledo JC, Bonalume Tacito LH, Ferreira-Melo SE, Sousa W, Consolin-Colombo F, Irigoyen MC, Franchini K, Coelho OR, Moreno H Jr. Low-renin (volume dependent) mild-hypertensive patients have impaired flow-mediated and glyceryl-trinitrate stimulated vascular reactivity. Circ J. 2005 Nov;69(11):1380-5. doi: 10.1253/circj.69.1380.
Results Reference
background
PubMed Identifier
11136953
Citation
Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
Results Reference
background
PubMed Identifier
17428822
Citation
Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.
Results Reference
background
PubMed Identifier
23985432
Citation
Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovacs SJ, Kolias TJ. Low-sodium DASH diet improves diastolic function and ventricular-arterial coupling in hypertensive heart failure with preserved ejection fraction. Circ Heart Fail. 2013 Nov;6(6):1165-71. doi: 10.1161/CIRCHEARTFAILURE.113.000481. Epub 2013 Aug 28.
Results Reference
result
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
result
PubMed Identifier
26497755
Citation
Mathew AV, Seymour EM, Byun J, Pennathur S, Hummel SL. Altered Metabolic Profile With Sodium-Restricted Dietary Approaches to Stop Hypertension Diet in Hypertensive Heart Failure With Preserved Ejection Fraction. J Card Fail. 2015 Dec;21(12):963-7. doi: 10.1016/j.cardfail.2015.10.003. Epub 2015 Oct 20.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23033371
Description
Hypertension publication from this study

Learn more about this trial

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

We'll reach out to this number within 24 hrs