Objective: To determine the (added) value of molecular imaging techniques for selecting patients that will benefit from CRT.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
-99mTc-Tetrofosmin(MPS)-based dyssynchrony and infarct burden measurements
-123I-metaiodobenzylguanidine(MIBG)-based Heart-to-Mediastinum(H/M)-ratio and
washout measurements
-Mismatch in regional distribution between MPS and MIBG
The main study parameters will be compared to response to CRT as defined by:
A: Reduction in NYHA class and increase in LVEF >= 5%
or
B: Reduction in LVESV >= 15%.
or
C: A composite of A + B.
Secondary outcome
in patients with CRT-D implants, MPS/MIBG mismatch will be correlated to
adequate discharge of the defibrillator and/or documented ventricular
arrhythmia during the follow-up period.
Background summary
Rationale: Cardiac resynchronization therapy (CRT) is an effective therapy for
heart failure patients with electromechanical ventricular dyssynchrony.
Optimization of selection criteria is necessary as with the current criteria up
to a third of patients undergoing this costly and invasive therapy do not
benefit from it.
We hypothesize that adding selection criteria based on molecular imaging
techniques (i.e. parameters of myocardial perfusion and myocardial sympathetic
activity) can further help distinguish responders from non-responders.
Study objective
Objective: To determine the (added) value of molecular imaging techniques for
selecting patients that will benefit from CRT.
Study design
Study design: Prospective single center non-randomised study with non-invasive
measurements.
Study burden and risks
99mTc-Tetrofosmin myocardial perfusion imaging (MPI) is standard-of-care for
CRT patients to identify infarct size and location. The added measurements are
post-processing only and do not pose any additional burden on the patient.
123I-MIBG myocardial sympathetic nerve activity imaging (MIBG) will be added in
a single-acquisition-study dual-isotope imaging design, adding approximately 3
hours and 2.4 milliSievert (mSv) of radiation burden to the study, as opposed
to more than 4 hours on another day in a standard dual-timepoint imaging
design, minimising the time burden for the patient.
There is no direct benefit for the patient from these measurements. However,
the results of the study may benefit all future CRT patients by better
identifying responders and minimising the amount of unnecessary CRT-device
implantations.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
-Informed consent obtained
-Chronic heart failure;
-New York Heart Association functional class II, III or IV;
-QRS duration >=150 ms for NYHA class II or >=120 ms for NYHA class III/IV;
-Optimal pharmacological therapy;
-Left ventricular ejection fraction <=35%.
Exclusion criteria
-Contraindications for implantation of a CRT device;
-Age <18 years or incapacitated adult;
-Pregnancy;
-Severe aortic stenosis with a valve area or aortic valve replacement in history;
-Known allergic reaction to iobenguane;
-Participation in another clinical study that prohibits any procedures other than standard.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38102.041.12 |