Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)
2018年6月4日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
18
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
他の名前：
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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アクティブコンパレータ：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.
他の名前：
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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Urinary F2-Isoprostanes
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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24-hour ambulatory blood pressure (mean and diurnal variation)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Scott L Hummel, MD MS、University of Michigan
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年9月18日
一次修了 (実際)
2015年11月18日
研究の完了 (実際)
2016年2月16日
試験登録日
最初に提出
2013年8月21日
QC基準を満たした最初の提出物
2013年9月13日
最初の投稿 (見積もり)
2013年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月6日
QC基準を満たした最後の更新が送信されました
2018年6月4日
最終確認日
2018年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。