ISRCTN86879094已完成未知

Exercise training in Diastolic Heart Failure: A prospective, randomized, controlled study to determine the effects of exercise training in patients with heart failure and preserved ejection fraction

Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)0 个研究点目标入组 320 人开始时间: 2011年10月6日最近更新: 2024年1月22日

适应症

试验速览

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28516519/ protocol (added 12/08/2020)

•1. Stable symptomatic heart failure with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology: Paulus et al., 2007):
•1.1. New York Heart Association (NYHA) II-III, peak VO2 < 25 ml/kg/min
•1.2. Left ventricular ejection fraction (LVEF) = 50%
•1.3. Ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E') (E/e)' > 15 or (E/e') > 8 < 15
•1.4. N-terminal pro-B-type natriuretic peptide (NTproBNP) > 220 ng/L
•1.5. Atrial fibrillation
•2. Age =18 years
•3. Symptom severity and heart failure medication were stable during the last 4 weeks
•4. Written informed consent of the patient

•1. Non-cardiac causes for heart failure like symptoms:
•1.1. Chronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages = II (moderate, severe, very severe)
•1.2. Anaemia (<11mg/dl)
•1.3. Significant renal dysfunction estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 body surface area (BSA)
•1.4. Significant peripheral artery disease (Fontaine = IIb)
•1.5. Musculoskeletal disease that contribute to reduced exercise performance
•1.6. Specific cardiomyopathy (e.g. amyloidosis etc.)
•1.7. Haemodynamically significant valvular disorders
•2. Significant coronary artery disease (CAD) [current angina pectoris, Canadian Cardiovascular Society (CCS) = II or positive stresstest, myocardial infarction or coronary artery bypass graft within the last 3 months)
•3. Any inability or contraindication to participate in ergospirometric testing or in an exercise program (e.g. physiological, mental) or supply essential information (e.g. questionnaire, diary)
•4. Ineffective control of resting blood pressure (BP >=140/90mmHg or BP >= 160/100mmHg with >= 3 antihypertensive drugs) or of resting heart rate (HR >= 100bpm)
•5. Expected low compliance (e.g. by travel distance to trial site; planned absences longer than 4 weeks during follow up) or ongoing drug abuse
•6. Concomitant participation in other interventional clinical trials

发起方

Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)