Diastolic Heart FailureDASH-DHFNCT00939640
Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure
A study testing DASH/sodium-restricted diet (SRD) in people with Diastolic Heart Failure and Hypertensive Heart Disease, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diastolic Heart Failure, Hypertensive Heart Disease
- What is being tested?
- DASH/sodium-restricted diet (SRD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet on Ventriculovascular Function in Heart Failure With Preserved Systolic Function
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.
- Being tested
- DASH/sodium-restricted diet (SRD)
- Keywords
- Diet, Sodium, Hypertension, Potassium, Antioxidants, congestive heart failure, Heart failure with normal ejection fraction, Heart failure with preserved systolic function
- Medical subject headings
- Heart Failure, Diastolic, Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH/sodium-restricted diet (SRD)Behavioural
Also called DASH diet, sodium-restricted diet, low sodium diet, DASH-sodium
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | 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. Receives: Behavioral: DASH/sodium-restricted diet (SRD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-mediated Dilation (FMD)
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Secondary outcomes (7)
Mean 24-hour Systolic Blood Pressure
Change in 24-hour systolic blood pressure
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
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
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
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.
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Carotid-femoral Pulse Wave Velocity
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Ventricular Diastolic Function
Lateral mitral annulus E/e' ratio
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Six Minute Walk Test Distance
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Urinary 8-isoprostanes
Measured: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott L. Hummel, University of Michigan
- Investigators
- Scott L Hummel, MD MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939640
- Sponsor's protocol ID
- HUM00025253
- Acronym
- DASH-DHF
- Status last verified
- Oct 2019
- First submitted
- 14 Jul 2009
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16855265Redfield 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.
PubMed 12517230Klotz 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.
PubMed 16585423Laffer 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.
PubMed 16432053Dekleva 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.
PubMed 17003543Yugar-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.
PubMed 16247215Sacks 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.
PubMed 11136953Paulus 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.
PubMed 17428822Hummel 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.
PubMed 23985432Hummel 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.
PubMed 23033371Mathew 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.
PubMed 26497755
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet on Ventriculovascular Function in Heart Failure With Preserved Systolic Function
- ClinicalTrials.gov ID
- NCT00939640
- Acronym / sponsor ID
- DASH-DHF / HUM00025253
- Keywords
- Diet, Sodium, Hypertension, Potassium, Antioxidants, congestive heart failure, Heart failure with normal ejection fraction, Heart failure with preserved systolic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 22 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Behavioral: DASH/sodium-restricted diet (SRD)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH/sodium-restricted diet (SRD)Also: DASH diet, sodium-restricted diet, low sodium diet, DASH-sodiumBaseline 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. | Behavioural | Dietary intervention |
Primary outcome
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
7 secondary outcomes
Mean 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
Diurnal Variation in Ambulatory Blood Pressure
Time frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Aortic Augmentation Index
Time frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
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
Ventricular Diastolic Function
Time frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
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
Urinary 8-isoprostanes
Time frame: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16855265Owan 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.
- Background: PubMed 12517230Redfield 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.
- Background: PubMed 16585423Klotz 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.
- Background: PubMed 16432053Laffer 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.
- Background: PubMed 17003543Dekleva 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.
- Background: PubMed 16247215Yugar-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.
- Background: PubMed 11136953Sacks 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.
- Background: PubMed 17428822Paulus 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 publication: PubMed 23985432Hummel 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 publication: PubMed 23033371Hummel 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 publication: PubMed 26497755Mathew 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.
- Hypertension publication from this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott L Hummel, MD MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH/sodium-restricted diet (SRD) in people with Diastolic Heart Failure and Hypertensive Heart Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00939640, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.