Studies / Cardiac insufficiency

 

Cardiac insufficiency: SMARTEX Study

Targeted training up to maximum capacity can considerably improve prognosis for cardiac patients. This can greatly increase chances of survival among men and women with chronic cardiomyopathy. This was proven by the European SMARTEX-HF Study that we brought into being in 2009.

Initial position
Until around ten years ago, doctors were very cautious about recommending physical exercise in patients with cardiomyopathy (where the heart’s ability to act as a pump is limited). The fear of dangerous cardiac arrhythmia and deterioration of the heart’s performance as it has to work harder under physical strain was too great.
In 2009, a large American study showed that regular, moderate training reduced readmissions to hospital for deterioration of cardiovascular performance. Exercise remodelled the worn-out heart - a complementary effect to medication. However, the dosage, i.e. the intensity of training, was unclear.

Our initiatives
We wanted to find the best possible training programme for patients with cardiac insufficiency that would be as well-tolerated as it is effective. To this end, we examined 261 patients with moderate to severe cardiac insufficiency, in seven countries, together with colleagues from Trondheim, Copenhagen, Antwerp und Leipzig. We compared the suitability of training concepts over twelve months, dividing up the patients into three groups: moderate training, high-intensity interval training and a control group.

Results – benefits for patients
The results of the study show that there is no justification for the conservative strategy of taking things easy, because cardiac patients benefit from (intense) exercise. Deterioration of the pump function of the ventricle or cardiac arrhythmia is not a risk even with high-intensity interval training. Moderate-intensity training had the best effects.

Evaluation
The SMARTEX-HF Study is one of the world’s largest studies investigating different intensities of training over a long monitoring period of one year. We initiated the study and were one of the main coordinators, along with Leipzig, Trondheim and Antwerp. The study is considered a “landmark study” and received a lot of attention at international conferences.

Recommendation for patients
Under no circumstances should men and women with cardiac insufficiency undertake a physical training programme without supervision. We strongly recommend a health check, which must include echocardiogram, cardiopulmonary exercise test and stress echocardiography, to establish the patient’s individual physical capabilities, before embarking on a training programme. We can draw up a tailored training plan on the basis of the findings. This training plan should be continuously adapted, and supported with regular follow-up examinations.

Cardiac insufficiency: OptimEx Study

Optimizing Exercise Training in Prevention and Treatment of Heart Failure with preserved ejection fraction

Background:

Heart Failure with preserved left ventricular Ejection Fraction (HFpEF) is the only cardiovascular disease with increasing prevalence and incidence. A cardinal feature of the disease is substantially reduced exercise-tolerance associated with pathophysiological disturbances both centrally and peripherally. No pharmacological agent has yet shown to improve symptoms or prognosis. The most promising way to improve pathophysiology and deprived exercise-tolerance seems to be exercise training, but the optimal dose of exercise to improve and maximize clinical and mechanistic data are very limited.

Objective:
Aim of the clinical multi-center study is to assess the optimal exercise intervention in HFpEF that will best improve physical capacity and cardiovascular morbidity as well as parameters of physical fitness and quality of life.

Design:
•    Prospective randomized multi-center phase IIb clinical trail
•    3-arm intervention protocol: moderate intensity continuous training, high intensity interval training, control group
•    n = 180 (randomization 1:1:1)
•    Intervention for 1 year, 3 months supervised and 9 months home based exercise training
•    Primary endpoint: Change in peak oxygen uptake
•    Secondary endpoints: echocardiographic parameters, fitness level, quality of life, endothelial function, skeletal muscle function

Collaborations:
•    U. Wisloff, Norwegian University of Science and Technology, Norway
•    V. Adams, University of Leipzig, Germany
•    M. Halle, Technische Universität München, Germany
•    C. Vrints, Antwerp University Hospital, Belgium
•    B. Pieske, Charité Universitätsmedizin Berlin, Germany
•    W. Schmid, Vitaphone, Germany

Funding:
European Commission, Framework Program 7 (2013-2017)

More information:
ClinicalTrials.gov (NCT02078947)

Cardiac insufficiency: Ex-DHF Study

Exercise training in Diastolic Heart Failure

Background:
Heart failure with preserved ejection fraction (HFpEF) is a common disease, especially in the elderly. Typical risk factors are 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 no effective treatment but exercise training may be of potential benefit.

Objective:
Aim of this study is to find out whether regular supervised exercise training can improve patients symptoms, their quality of life and the course of the disease.

Design:
•    n=320 participants, randomized 1:1 into intervention group (endurance/strength training) and usual care
•    Supervised exercise training will be offered three times a week over 12 months
•    Primary endpoint is a combined outcome score (modified “Packer score”). This combined score classifies patients as worsened, unchanged or improved

Collaborations:
The study will be performed in Germany (20 trial sites).

Funding:
The German Research Foundation (DFG, Germany) funds the study (ISRCTN86879094).

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