Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)
4. června 2018 aktualizováno: Scott L. Hummel, University of Michigan
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.
Přehled studie
Postavení
Ukončeno
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
18
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: DASH/Sodium-Restricted Diet Intervention
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.
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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.
Ostatní jména:
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.
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Aktivní komparátor: Control Diet Intervention
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.
|
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.
Ostatní jména:
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.
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Žádný zásah: Healthy Control
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Urinary F2-Isoprostanes
Časové okno: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
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The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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24-hour ambulatory blood pressure (mean and diurnal variation)
Časové okno: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
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The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14
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Carotid-femoral pulse wave velocity
Časové okno: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
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The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14
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Six minute walk test distance
Časové okno: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
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The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14
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Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product
Časové okno: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
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The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14
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Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)
Časové okno: 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
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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
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Knowledge, skills and attitudes related to DASH/SRD
Časové okno: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
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Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires
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Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6
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Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells
Časové okno: 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
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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
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Scott L Hummel, MD MS, University of Michigan
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
18. září 2012
Primární dokončení (Aktuální)
18. listopadu 2015
Dokončení studie (Aktuální)
16. února 2016
Termíny zápisu do studia
První předloženo
21. srpna 2013
První předloženo, které splnilo kritéria kontroly kvality
13. září 2013
První zveřejněno (Odhad)
16. září 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
6. června 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HUM00052649
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .