Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04540289 |
Other study ID # |
LHI-2020-01 |
Secondary ID |
847999 |
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2021 |
Est. completion date |
January 31, 2023 |
Study information
Verified date |
September 2020 |
Source |
Leipzig Heart Institute GmbH |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35%
but high risk for SCD according to a personalised risk score, the implantation of an ICD
(index group) is superior to optimal medical therapy (control group) with respect to
all-cause mortality.
Description:
Sudden cardiac death (SCD) is a major public health problem, causing ~50% of cardiac
fatalities and accounting for ~20% of all deaths in Europe. Identification of patients that
are at risk for SCD and would benefit from ICD implantation is challenging. A predictor for
increased risk of SCD after MI is a severely impaired heart function as expressed by a
reduced left ventricular ejection fraction (LVEF). Based on this and on historical landmark
trials, which found improved survival in patients with severely reduced LVEF who received an
ICD, current clinical guidelines recommend prophylactic ICD implantation in post-MI patients
with a LVEF ≤35% to improve overall survival by prevention of SCD. The current use of LVEF as
sole patient stratification tool to guide treatment decisions for ICD implantation in
patients with prior coronary event, as is currently recommended by clinical guidelines and
performed in clinical practice, has significant limitations and results in substantial over-
and undertreatment of patients. In particular, there is conclusive evidence that the majority
of SCD cases occur in patients with only moderately reduced or preserved LVEF. Thus, with
current guidelines most of patients that will develop SCD are not protected by means of ICD
implantation.
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35%
but high risk for SCD according to a personalised risk score, the implanta-tion of an ICD
(index group) is superior to optimal medical therapy (control group) with respect to
all-cause mortality.
PROFID-Preserved is a non-commercial, investigator-driven, prospective, parallel-group,
randomised, open-label, blinded outcome assessment (PROBE), multi-centre, superiority trial
without dedicated investigational medical device (Proof of Strategy Trial) with two groups
with 1:1 randomi-sation. It will be conducted in about 12 European countries with more than
150 clinical sites participating.
This study is an event driven trial and the number of randomised patients is estimated to be
1,440, required to collect 297 first primary outcome events within 30 months of mean
follow-up.
Total study duration:
Enrolment of 30 months. All patients will be followed until 297 valid primary endpoints are
reached (event-driven trial) which is expected about 15 months after last patient in. Total
study duration of 47 months is expected which might be adapted based on a blinded interim
analysis of the overall occurrence of the primary endpoint.
Individual study duration:
Expected median follow-up time will be about 30 months per patient with a minimum follow-up
time of 15 months and a maximum follow-up time of presumably 45 months.