Chronic Heart Failure Clinical Trial
Official title:
Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure - An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial Without Investigational Medical Products (Proof of Strategy Trial)
The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to defibrillator (control group) with respect to all-cause mortality.
Heart failure is a leading cause of death, hospitalisation, impaired quality of life and
health expenditure. Symptoms and survival can be significantly improved by implantation of a
device for Cardiac Resynchronisation Therapy (CRT). CRT devices are available as
biventricular pacemakers (CRT-P) or as significantly more complex and cost-intensive
biventricular defibrillators (CRT-D).
In patients who have previously experienced a life-threatening arrhythmia, the choice of the
CRT-D (and not the CRT-P) is imperative but these are a small minority of patients. For the
vast majority of patients receiving CRT therapy, there is currently considerable uncertainty
as to whether the defibrillator function is needed and whether its benefits outweigh its
risks. The defibrillator function may protect patients from sudden cardiac death. On the
other hand, device-associated complications such as device infections appear to be increased;
furthermore the defibrillator comes along with specific adverse events, particularly
inappropriate shocks. These shocks are common and not only traumatic to patients (potentially
leading to post-traumatic stress syndrome, anxiety disorders and depression), they also are
negatively associated with overall survival.
The objective of the trial is to demonstrate that in patients with chronic heart failure who
receive optimal medical treatment for this condition and have indication for CRT, the
implantation of a CRT-P (index group) is not inferior to CRT-D (control group) with respect
to all-cause mortality. Patients with an indication for CRT will be randomised to CRT-P or
CRT-D.
RESET-CRT is an event-driven trial with a planned number of randomised and treated patients
of n=2,030 and of 361 primary endpoints within an estimated median follow-up period of 21
months.
No investigational medical product is defined to be used within RESET-CRT since only the
therapeutic strategy (CRT-D versus CRT-P) is a pre-defined study treatment and allocated by
random group (Proof of Strategy Trial). The devices to be implanted will be decided by the
treating physician on the basis of the situation of the individual study patient and in line
with local policies in routine clinical care.
Total study duration:
Enrolment of 24 months. All patients will be followed until 361 valid primary endpoints are
reached (event-driven trial) which is expected about 10 months after last patient in. Total
study duration of 35 months (about 3 years) is expected which might be adapted based on
blinded interim analysis of the overall occurrence of the primary endpoint.
Individual study duration:
Expected mean follow-up time will be about 21 months per patient with a minimum follow-up
time of 10 months and a maximum follow-up time of presumably 35 months.
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