Multicenter Trials - Project description
Background
Drug treatment for heart failure has undergone a fundamental transformation in the past 20 years. Today, beta blockers are indispensable. Their use is recommended by national and international specialist associations for all patients, regardless of age. Elderly patients are the largest group with heart failure: 90 percent of patients with heart failure are over 65 years of age. However, due to fear of side effects with multiple accompanying medications and comorbidity, this treatment is frequently withheld from elderly patients in particular. The situation is made more difficult by the fact that the average age of study patients has traditionally not reflected the older age of the population under investigation.
Objective
We want to develop an internationally recognized study group – „Multicentric Heart Failure Therapy Studies“ – with good organizational structures. The study group should be composed of staff members from the centers collaborating with the competence network and involve experts from all subspecialties in cardiology, cardiovascular surgery, biometrics and statistics. The purpose of this is to substantially improve the quality of clinical therapy studies in the area of heart failure.
Implementation
With our independent CIBIS-ELD study, we compare the tolerability of the beta-blocker treatment in a targeted fashion in older patients with heart failure. This is a prospective, randomized, double-blind study, and thus meets the toughest requirements for study design. More than 1,000 patients, who were treated with a low dosage before the study began, can be enrolled. During a period of twelve weeks, they will be treated with one of the two approved beta blockers bisoprolol or carvedilol. The dosage corresponds to current recommendations and will be adapted to the patient‘s individual tolerance. At the end of the study we will determine whether one of the two beta blockers was better tolerated or whether varying dosages were achieved. In another part of the study, patients who received a higher dose of beta blockers before the beginning of the study can also be enrolled. We want to establish the current status of heart failure treatment in Germany.
Added value via networking
The expertise in carrying out multicentric treatment studies is offered within the established structures of the Competence Network Heart Failure and outside the network, and used to carry out further studies. The demonstrated professionalism and neutrality in the implementation of the multicentric CIBIS-ELD treatment study will be made known to a professional audience. Collaboration with international work groups is desired. The label „Competence Network Heart Failure“ as the initiator of multicentric treatment studies will be established as a guarantee of a professionally and neutrally conducted study.