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

Diastolic Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939640
• Other study ID #: HUM00025253
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Diseases
• Heart Failure
• Heart Failure, Diastolic
• Hypertension
• Hypertensive Heart Disease

Intervention

Behavioral:
• DASH/sodium-restricted diet (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. 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Epub 2006 Sep 25. — View 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 e — View Citation

Hummel SL, Seymour EM, Brook RD, Sheth SS, Ghosh E, Zhu S, Weder AB, Kovács 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. — View 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. Epub 2006 Apr 3. — View 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. Epub 2006 Jan 23. — View 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: 1 — View 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. — View Citation

Paulus WJ, Tschöpe C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbély 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. Epub 2007 Apr 11. — View 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. — View 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. — View Citation

Yugar-Toledo JC, Bonalume Tácito 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EndoPAT Arterial Endothelial Function		Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Other	Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product	Safety measures to determine adverse effects of the provided DASH diet home-delivered meals	Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Primary	Brachial Artery Flow-mediated Dilation (FMD)		Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	Mean 24-hour Systolic Blood Pressure	Change in 24-hour systolic blood pressure	Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	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	Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	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.	Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	Carotid-femoral Pulse Wave Velocity		Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	Ventricular Diastolic Function	Lateral mitral annulus E/e' ratio	Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	Six Minute Walk Test Distance		Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary	Urinary 8-isoprostanes		Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation

External Links

•   Hypertension publication from this study