Congenital Heart Disease, Congenitally Corrected Transposition of the Great Arteries, Heart Failure Congenital, Systemic Right Ventricle, Transposition of Great Vessels
Conditions
Keywords
cardiac resynchronization therapy, congenital heart disease, systemic right ventricle, heart failure
Brief summary
The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.
Detailed description
This study will be the first to bring evidence on CRT efficacy in ACHD patients with heart failure and SRV. If results are positives, CRT may improve functional capacities and quality of life of patients and will become an option of choice in this population. If results are negatives, futile CRT implantation may be avoided in this population in particular considering potential adverse effects and CRT-related complications. Double blind randomized cross-over trial. 40 patients will be enroled. Their follow-up will be 6 months.
Interventions
DEVICECRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
Patients randomized to the CRT ON / CRT OFF arm will undergo a first intervention to activate their device and then a second intervention for 3 months to inactivate their device.
DEVICECRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Patients randomized to the CRT OFF / CRT ON arm will undergo a first intervention to inactivate their device and then a second intervention for 3 months to activate their device.
Sponsors
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double blind randomized cross-over trial. Two cross-over periods of 3 months comparing biventricular pacing (CRT ON) vs. inactive pacing (ventricular back-up pacing or left ventricular pacing alone in patients requiring pacing, CRT OFF), each period in random order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* systemic right ventricle (SRV), * CRT-P or CRT-D device implanted for at least 1 month, * Age ≥18 years old, * One of the two following CRT indications: * NYHA II-IV, right ventricular ejection fraction ≤ 35% and spontaneous QRS duration ≥ 150 ms Or * NYHAI-IV, atrioventricular conduction disorders with ventricular pacing \> 40% (regardless right ventricular ejection fraction). * Affiliation to a french social security system (beneficiary or legal) * Informed and signed consent
Exclusion criteria
* Pregnancy or breastfeeding * Women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * Patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization), * Cardiac surgery during the last 3 months or planned during the next 6 months, * Percutaneous structural cardiac intervention planned during the next 6 months, * Persistent atrial arrhythmia with catheter ablation planned during the next 6 months, * Acute congestive heart failure, * Dysfunction of at least one CRT device lead that compromise biventricular pacing, * Patient on AME * Current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | The 6-minute walk test will be performed by a trained technician, indoors, along a long, flat, straight, enclosed corridor with a hard surface and a minimal length of 30 meters. The length of the corridor will be marked every 3 meters and the turnaround points will be marked with a cone. The starting line will be marked on the floor using brightly colored tape. Specific and standardized instructions will be transmitted to the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QRS duration | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | QRS duration measured on electrocardiogram |
| Quality of life of patients | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Minnesota living with heart failure and SF36v2 questionnaires |
| BNP | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | BNP level |
| Heart failure | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Number of hospitalizations for heart failure |
| Diuretics | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Dose of diuretics prescribed |
| Premature cross-over phase termination | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Number of patients with need for premature cross-over phase termination to restore previous pacing settings |
| Ventricular arrhythmias | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Number of non-sustained and sustained ventricular arrhythmias |
| Peak oxygen uptake | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | VO2 max (ml/kg/min) during exercise test with standardized protocol, |
| NYHA classification | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | NYHA classification (class I to IV) |
| Tricuspid valve regurgitation | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography |
| Right ventricular ejection fraction | Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months) | Right ventricular ejection fraction assessed by echocardiography (%) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVictor WADLMANN
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed