Exercise training in Diastolic Heart Failure

Mise à jour : Il y a 4 ans
Référence : ISRCTN86879094

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Background and study aims Heart failure with preserved ejection fraction (HFpEF) is one of the three main types of heart failure. It is a common disease, especially in the elderly. Typical risk factors are high blood pressure (hypertension), diabetes, and an inappropriate lifestyle. The consequences are substantial functional limitations and poor quality of life. Patients are also less able to exercise and this has a negative effect on the disease. Currently there is currently no effective treatment but exercise training may be of potential benefit. In this study we want to find out whether regular supervised exercise training can improve patients’ symptoms, their quality of life and the course of the disease. Who can participate? To take part you need to be aged 18 years old or above and have been diagnosed with HFpEF. What does the study involve? You will receive either individually prescribed supervised exercise training on top of usual care or usual care alone. Usual care involves normal and established control of risk factors such as hypertension or high blood cholesterol levels (hyperlipidemia) for 12 months. The allocation to training or usual care will be by chance. Only one half of the patients will receive exercise training. During the 1-year follow-up period, there will be 5 visits (including blood samples, exercise testing and echocardiography). What are the possible benefits and risks of participating? Supervised individually tailored exercise training in stable heart failure patients appears to be a safe treatment , even in elderly patients. In an initial study patients with the same disease were included and there were no adverse events. Exercise may trigger myocardial ischemia (decreased blood flow to the heart) or arrhythmias (irregular heart beat), exercise-related cardiac decompensation (failure of the heart to maintain adequate blood circulation) and inappropriate blood pressure increases. We will minimise these risks by implementation of strict inclusion/exclusion criteria for participants (e.g., blood pressure control, no symptomatic coronary artery disease, inclusion of compensated patients only) and careful evaluation before participation in the study. In addition, you will undergo an exercise stress test (spiroergometry) and echocardiography before inclusion, and if we expect any exercise-related unfavourable side effects, you will not be included in the study. Your training intensity will be individually adjusted on the basis of pre-specified criteria (e.g., heart rate). This will be re-evaluated every 3 months, and individual adaptations of training intensity will be performed, if needed. This procedure ensures that training intensity is always under medical control. Exercise training will be supervised by trained supervisors (e.g., physiotherapists). With the use of safety measures such as permanent supervision and very regular visits, we expect few adverse events.. On the other hand, we do expect significant beneficial effects. The clinical benefit is expected to largely outweigh potential reversible and non-life-threatening side effects. Where is the study run from? The study will be performed in Germany and Austria (20 trial sites). When is study starting and how long is it expected to run for? Patients will be enrolled in the study between September 2011 and September 2013. Follow-up examinations will continue until October 2014. Who is funding the study? The study is funded by the German Research Foundation (Germany). Who is the main contact? Dr F Edelmann [email protected]


Critère d'inclusion

  • Heart failure with preserved ejection fraction (HFpEF, i.e. diastolic heart failure)

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