Clinical trial NCT05524324: Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
Official title: Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Systemic Right Ventricle
Congenitally Corrected Transposition of the Great Arteries
Transposition of Great Vessels
Heart Failure Congenital
Keywords: cardiac resynchronization therapy
congenital heart disease
systemic right ventricle
heart failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-minute walk test
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary outcomes:
measure: Peak oxygen uptake
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: NYHA classification
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Right ventricular ejection fraction
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Tricuspid valve regurgitation
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: QRS duration
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Quality of life of patients
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: BNP
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Heart failure
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Diuretics
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Premature cross-over phase termination
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
measure: Ventricular arrhythmias
timeFrame: Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Le Plessis-Robinson
country: France
facility: Hôpital Marie-Lannelongue
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Marseille
country: France
facility: Hôpital La Timone
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Ap-Hp Hegp
city: Paris
country: France
facility: AP-HP, Pitié-Salpétrière
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Victor WADLMANN
role: PRINCIPAL_INVESTIGATOR
References: