Primary Objective: to determine the prevalence of MTWA in adults with congenital heart disease who are deemed to be at high risk for ventricular arrhythmias and sudden cardiac death.Secondary Objective(s): • to describe the clinical usefulness and…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of MTWA
Secondary outcome
The occurrence of the following events in patients with negative, indeterminate
or positive MTWA
o Ventricular arrhythmias
o Sudden cardiac death
o Cardiac death
o All-cause mortality
Background summary
Sudden cardiac death (SCD) is one of the main causes of mortality in adults
with congenital heart disease. Risk stratification for SCD is difficult,
because it is still unclear which risk factors contribute to a heightened risk
of SCD.
Implantation of an implantable cardioverter-defibrillator is often complicated
mainly by ICD lead or shock generator failure or inappropriate ICD shocks.
Previous research has shown that a microvolt T-wave alternans (MTWA) can
predict ventricular arrhythmias and SCD within the next 1-2 years in patients
with non-ischemic or ischemic cardiomyopathy.
MTWA could also predict SCD and ventricular arrhythmias in adults with
congenital heart disease.
Study objective
Primary Objective: to determine the prevalence of MTWA in adults with
congenital heart disease who are deemed to be at high risk for ventricular
arrhythmias and sudden cardiac death.
Secondary Objective(s):
• to describe the clinical usefulness and predictive value of MTWA for
ventricular arrhythmia events, all-cause mortality and cardiac death.
• Comparison between the MTWA-positive, -indeterminate and -negative groups and
between negative and non-negative groups.
Study design
A prospective, multicentre observational study with a minimum follow up
duration of one year.
Study burden and risks
Patients will undergo a bicycle exercise test, during which only a moderate
exercise is delivered and the heart rate will go up to 120 beats per minute.
This is a non-invasive test which is considered to be not hazardous to patients
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Diagnosed with a congenital heart defect
• Age >= 18 years old
• History of ventricular arrhythmias
or
Implantable cardioverter-defibrillator implanted for primary or secondary prevention of sudden cardiac death
or
A high risk of SCD (>=3% annual risk) according to the risk score or ICD indication according to the consensus statement on arrhythmias in CHD as identified in the PREVENTION-ACHD study (NL50152.018.14).
Exclusion criteria
• Persistent or permanent atrial fibrillation.
• Ventricular pacing
• NYHA class III or IV symptoms
• Inability to perform exercise otherwise
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 | NL55036.018.15 |