Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

Congenital Heart Disease Clinical Trial

— RIGHT-CRT  

Official title:

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05524324
• Other study ID #: APHP211040
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: March 2025

Study information

• Verified date: December 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Karine Goude
• Phone: +33 1 44 84 17 22
• Email: karine.goude[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Congenitally Corrected Transposition of the Great Arteries
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• Situs Inversus
• Systemic Right Ventricle
• Transposition of Great Vessels

Intervention

Device:
• CRT 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.
• CRT 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.

Locations

Country	Name	City	State
France	CHU de Caen	Caen
France	Hôpital Marie-Lannelongue	Le Plessis-Robinson
France	CHU de Lille	Lille
France	Hôpital Louis Pradel	Lyon
France	Hôpital La Timone	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	AP-HP, Pitié-Salpétrière	Paris
France	CHU de Rouen	Rouen
France	CHU de Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	CHU de Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test	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.	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Peak oxygen uptake	VO2 max (ml/kg/min) during exercise test with standardized protocol,	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	NYHA classification	NYHA classification (class I to IV)	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Right ventricular ejection fraction	Right ventricular ejection fraction assessed by echocardiography (%)	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Tricuspid valve regurgitation	Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	QRS duration	QRS duration measured on electrocardiogram	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Quality of life of patients	Minnesota living with heart failure and SF36v2 questionnaires	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	BNP	BNP level	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Heart failure	Number of hospitalizations for 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)
Secondary	Diuretics	Dose of diuretics prescribed	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Premature cross-over phase termination	Number of patients with need for premature cross-over phase termination to restore previous pacing settings	Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary	Ventricular arrhythmias	Number of non-sustained and sustained 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)