Diastolic Heart FailureNCT01942395
Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)
A study testing DASH/sodium-restricted diet (DASH/SRD) in people with Diastolic Heart Failure and Hypertensive Heart Disease, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diastolic Heart Failure, Hypertensive Heart Disease
- What is being tested?
- DASH/sodium-restricted diet (DASH/SRD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2012to 16 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- DASH/sodium-restricted diet (DASH/SRD), Control Diet
- Keywords
- Diet, Sodium, Hypertension, Potassium, Antioxidants, Congestive Heart Failure, Heart failure with normal ejection fraction, Heart failure with preserved ejection fraction
- 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 (DASH/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. 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.
Control DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DASH/Sodium-Restricted Diet Intervention | Active comparator | 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. Receives: Behavioral: DASH/sodium-restricted diet (DASH/SRD); Behavioral: Control Diet |
| Control Diet Intervention | Active comparator | 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. Receives: Behavioral: DASH/sodium-restricted diet (DASH/SRD); Behavioral: Control Diet |
| Healthy Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary F2-Isoprostanes
Measured: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
Secondary outcomes (7)
24-hour ambulatory blood pressure (mean and diurnal variation)
Measured: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
Carotid-femoral pulse wave velocity
Measured: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
Six minute walk test distance
Measured: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product
Measured: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)
Measured: 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
Knowledge, skills and attitudes related to DASH/SRD
Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires
Measured: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study start18 Sep 2012
- Primary completion18 Nov 2015
- Study completion16 Feb 2016
Why it stopped: study diet is no longer available to match with the previous participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 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
- NCT01942395
- Sponsor's protocol ID
- HUM00052649
- Status last verified
- Jun 2018
- First submitted
- 21 Aug 2013
- Last updated
- 6 Jun 2018
- Results posted
- No
- 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 16855265Hummel 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 23033371Al-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.
PubMed 19404315Borlaug 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.
PubMed 20813282
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)
- ClinicalTrials.gov ID
- NCT01942395
- Acronym / sponsor ID
- HUM00052649
- Keywords
- Diet, Sodium, Hypertension, Potassium, Antioxidants, Congestive Heart Failure, Heart failure with normal ejection fraction, Heart failure with preserved ejection fraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study diet is no longer available to match with the previous participants.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 18 Sep 2012 (actual)
- Primary completion
- 18 Nov 2015 (actual)
- Study completion
- 16 Feb 2016 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DASH/Sodium-Restricted Diet Intervention | Active comparator | Behavioral: DASH/sodium-restricted diet (DASH/SRD), Behavioral: Control DietEach 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. |
| Control Diet Intervention | Active comparator | Behavioral: DASH/sodium-restricted diet (DASH/SRD), Behavioral: Control DietPatients 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. |
| Healthy Control | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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%
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 (DASH/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. 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. | Behavioural | Control Diet Intervention, DASH/Sodium-Restricted Diet Intervention |
| Control DietThe 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. | Behavioural | Control Diet Intervention, DASH/Sodium-Restricted Diet Intervention |
Primary outcome
Urinary F2-Isoprostanes
Time frame: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
7 secondary outcomes
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
Carotid-femoral pulse wave velocity
Time frame: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
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
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
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
Knowledge, skills and attitudes related to DASH/SRD
Time frame: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
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
Results and safety
The study was stopped early (reason given: study diet is no longer available to match with the previous participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- 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 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.
- Background: PubMed 19404315Al-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.
- Background: PubMed 20813282Borlaug 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.
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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 (DASH/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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 6 Jun 2018. 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?
The study was stopped early (reason given: study diet is no longer available to match with the previous participants.). Results are not available in the source record.
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?
Urinary F2-Isoprostanes (time frame: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14). 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 NCT01942395, which also lists 4 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 6 Jun 2018.