Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
Multi-Disciplinary Rehabilitation Program in Recently Hospitalized Patients With Preserved Ejection Fraction Heart Failure
The purpose of this prospective study is to determine whether comprehensive cardiac rehabilitation is superior to usual disease management in the treatment of patients with heart failure with preserved systolic function (HFpEF) recently discharged after an acute heart failure event.
The investigators hypothesize that the addition of bi-weekly structured exercise training and interaction with medical personnel will lead to a greater reduction in all cause hospitalization and mortality while providing additional functional and clinical benefits such as exercise capacity, quality of life and well-being.
Furthermore the investigators seek to establish clinical, laboratory and echocardiographic predictors of hospital readmissions and cardiovascular events in the predefined HFpEF population.
調査の概要
詳細な説明
Our primary objective is to test the hypothesis that comprehensive multi-disciplinary cardiac rehabilitation program is superior to usual care in the treatment of patients with HFpEF discharged after an acute heart failure event, and will result in a 25% reduction in the composite outcome of all cause hospitalizations and all-cause mortality after 1-year of follow-up. This objective represents both safety and efficacy end-point in a patient population with a high rate of co-morbidities, which may be affected as well. Previous observation has shown that these patients have a high rate of non-cardiac death in comparison with HFrEF, thus enhancing the importance of all-cause hospitalization and mortality as a primary end-point.
Secondary end-points that will be recorded include separate components of the primary end-point, time to first hospitalization, functional capacity measured by NYHA class, 6-minute walk test (6MWT), blood pressure during rest and exercise, fasting glucose and Hb A1C levels, BNP values and quality of life EQ5-D questionnaire.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Ramat Gan、イスラエル
- 募集
- Sheba Medical Center
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コンタクト：
- Nava Levine Tiefenbrun, Dr.
- メール：Nava.LevineTiefenbrun@sheba.health.gov.il
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Tel Hashomer , Ramat Gan、イスラエル
- まだ募集していません
- Sheba Medical Center, Cardiac Rehabilitation Institute
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コンタクト：
- Robert Klempfner, MD
- 電話番号：+972525506852
- メール：klempfner@gmail.com
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コンタクト：
- Merav Moreno, Msc
- メール：Merav.Moreno@sheba.health.gov.il
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副調査官：
- Robert Klempfner, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients >=21 years of age willing and able to sign consent forms
- Hospitalization for acute heart failure (AHF) in one of the internal medicine departments participating in the study
AHF as the primary diagnosis as defined by:
- (I) The presence of pulmonary congestion or edema on chest radiography OR
- (II) Evidence of fluid retention (pedal edema, pleural effusion, ascites) not otherwise explained by other conditions (i.e. malignancy, nephrotic syndrome, liver cirrhosis, severe hypo-albuminemia, etc) AND
(III) Echocardiography demonstrating the presence of preserved systolic function
- In cases where diagnosis is unclear BNP testing (with a cutoff value of >300 ng/dl) will be used.
- If there is clinical suspicion of pulmonary disease investigators are encouraged to perform pulmonary function tests after the patient condition is stabilized.
- Preserved systolic function as determined by in-hospital or recent (within 3 months) echocardiographic examination according to ESC guidelines and in the absence of hemodynamic significant valvular disease.
- Stable clinical condition prior to discharge permitting the initiation of an exercise training program
Exclusion Criteria:
- Hemodynamically significant valvular disease (severity > mild other than TR)
- Acute coronary syndrome as the primary diagnosis
- End stage heart failure - NYHA IV
- Severe renal dysfunction - eGFR<30 ml/min/1.73m2 or renal replacement therapy
- Inability to participate in an exercise program and comply with study protocol
- Severe chronic obstructive pulmonary disease (COPD) (FEV1<50%) or asthma defined as severe
- First episode of a hypertensive crisis event (without history of chronic heart failure)
- Cognitive decline or major psychiatric pathology
- Non ambulatory condition
- Life expectancy < 12 months
- Substance dependency
- Inability to participate due to technical barriers such as a significant distance from a cardiac rehabilitation center
研究計画
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：並列代入
- 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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実験的：Cardiac Rehabilitation
Patients randomized to the multidisciplinary cardiac management program at the cardiac rehabilitation center will undergo evaluation by a trained rehabilitation physician and physiologist.
The evaluation will include medical history, physical examination, vitals, review of post discharge graded exercise stress test and nursing staff consultation.
Exercise prescription will be based on a pre-specified protocol in accordance with ESC position paper on cardiac rehabilitation of patients with heart failure.
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Patients will participate in a 6-month cardiac rehabilitation program, consisting of structured, 60-minutes, bi-weekly exercise training sessions according to a predefined protocol.
Institutional activity will be complemented by 120 minutes weekly home exercise prescribed by specialist in cardiac rehabilitation.
Exercise prescription will be based on a symptom limited exercise test when clinically feasible and according with the patients' functional capacity, medical history and physiological values obtained prior to exercise.
Target heart rate will be set initial as 50-60% of heart rate reserve and gradually increased up to 80% of HRR.
Aerobic exercise will be complemented by resistance training of low intensity.
他の名前：
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アクティブコンパレータ：Internal Medicine
Following discharge, patients will return to the internal medicine (IM) outpatient clinics at 2-4 weeks, 3, and 6 months for consultation.
These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated.
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Following discharge, patients will return to the IM outpatient clinics at 2-4 weeks, 3, and 6 months for consultation.
These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated.
Target values for blood pressure and glucose control will be in accordance with current guidelines and special emphasis given to management of fluid retention.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Combined primary endpoint
時間枠：12 months following randomization
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Combined all-cause mortality and hospitalizations at a 12-months follow-up
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12 months following randomization
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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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Secondary endpoint - change in functional capacity and clinical status
時間枠：3 and 6 month follow-up after randomization
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Secondary clinical outcomes will be collected during the 3 and 6 month follow-up visits and will include: blood pressure averages , HbA1C levels, assessment of NYHA class and global clinical assessment , 6-minute walk test and quality of life data as evaluated by the EQ-5D questionnaire
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3 and 6 month follow-up after randomization
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All cause mortality end-point
時間枠：12 months after randomization
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12 months after randomization
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Heart failure hospitalizations
時間枠：12 months after randomization
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Number of HF hospitalizations as assessed by HF specialists blinded to patients allocation.
Assessment will include medical record and hospital discharge letter review.
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12 months after randomization
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Stankovic I, Neskovic AN, Putnikovic B, Apostolovic S, Lainscak M, Edelmann F, Doehner W, Gelbrich G, Inkrot S, Rau T, Herrmann-Lingen C, Anker SD, Dungen HD. Sinus rhythm versus atrial fibrillation in elderly patients with chronic heart failure--insight from the Cardiac Insufficiency Bisoprolol Study in Elderly. Int J Cardiol. 2012 Nov 29;161(3):160-5. doi: 10.1016/j.ijcard.2012.06.004. Epub 2012 Jun 21.
- Steinberg BA, Zhao X, Heidenreich PA, Peterson ED, Bhatt DL, Cannon CP, Hernandez AF, Fonarow GC; Get With the Guidelines Scientific Advisory Committee and Investigators. Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes. Circulation. 2012 Jul 3;126(1):65-75. doi: 10.1161/CIRCULATIONAHA.111.080770. Epub 2012 May 21.
- Lewis BS, Shotan A, Gottlieb S, Behar S, Halon DA, Boyko V, Leor J, Grossman E, Zimlichman R, Porath A, Mittelman M, Caspi A, Garty M; HFSIS Investigators. Late mortality and determinants in patients with heart failure and preserved systolic left ventricular function: the Israel Nationwide Heart Failure Survey. Isr Med Assoc J. 2007 Apr;9(4):234-8.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
Cardiac Rehabilitationの臨床試験
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Medtronic Cardiac Rhythm and Heart FailureMedtronic International Trading Sarl完了
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Medtronic Cardiac Rhythm and Heart Failure完了
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Uppsala University HospitalMedtronic; Swedish Heart Lung Foundationわからない
-
St. Luke's-Roosevelt Hospital Center完了
-
Medtronic Cardiac Rhythm and Heart Failure完了
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Medtronic Cardiac Rhythm and Heart Failure募集