STUDY FINDINGS

THE TRANSFERABILITY OF STUDIES TO CLINICAL PRACTICE

Please allow us to describe the transferability of studies to medical practice by using an example: The CIBIS-II, MERIT-HF, and COPERNICUS randomized trials have statistically proven that symptomatic HF patients (i.e. patients suffering from a weak heart) will profit from beta blocker therapy (Domanski et al., J Card Fail. 2003 Oct; 9 (5): 354-63).

However, randomized trials do enroll only selected patients. In MERIT-HF, for example, patients suffering from acute myocardial infarction at the time of enrollment were excluded from the study. In addition, younger patients are preferred because it is, among other things, easier and faster to inform them about the study and obtain the legally required informed consent for enrollment in the trial, compared to older patients.

Scrutinize, Adjust & Update!

Based on HF registry data, Stiftung IHF has investigated which portion of all symptomatic heart failure (HF) patients are represented in the MERIT-HF study. This resulted in the finding that two thirds of all symptomatic HF patients treated on an inpatient basis under real-world conditions were not covered by the MERIT-HF study. What about these patients? Do they profit from beta blocker therapy as well? To answer that question, the foundation has investigated these patients with view to 1-year mortality with and without beta blocker therapy.

The HF registry shows that the mortality rate of patients not covered by the MERIT-HF study was significantly higher than the rate in the study population, and that these patients also benefit from beta blocker therapy (1-year mortality without beta blocker 24%, with beta blocker 12%).