Back to resultsCardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT (RIGHT-CRT)
Primary Purpose
Congenital Heart Disease, Systemic Right Ventricle, Congenitally Corrected Transposition of the Great Arteries
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease focused on measuring cardiac resynchronization therapy, congenital heart disease, systemic right ventricle, heart failure
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.
Sites / Locations
- CHU de Caen
- Hôpital Marie-Lannelongue
- CHU de Lille
- Hôpital Louis Pradel
- Hôpital La Timone
- CHU de Montpellier
- CHU de Nantes
- AP-HP, Pitié-Salpétrière
- CHU de Rouen
- CHU de Toulouse
- Clinique Pasteur
- CHU de Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Arm Description
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT ON" then "CRT OFF" mode.
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT OFF" then "CRT ON" mode.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Peak oxygen uptake
VO2 max (ml/kg/min) during exercise test with standardized protocol,
NYHA classification
NYHA classification (class I to IV)
Right ventricular ejection fraction
Right ventricular ejection fraction assessed by echocardiography (%)
Tricuspid valve regurgitation
Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography
QRS duration
QRS duration measured on electrocardiogram
Quality of life of patients
Minnesota living with heart failure and SF36v2 questionnaires
BNP
BNP level
Heart failure
Number of hospitalizations for heart failure
Diuretics
Dose of diuretics prescribed
Premature cross-over phase termination
Number of patients with need for premature cross-over phase termination to restore previous pacing settings
Ventricular arrhythmias
Number of non-sustained and sustained ventricular arrhythmias
Full Information
NCT ID
NCT05524324
First Posted
July 12, 2022
Last Updated
August 29, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT05524324
Brief Title
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
Acronym
RIGHT-CRT
Official Title
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: A Cross-Over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
Arm Type
Other
Arm Description
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT ON" then "CRT OFF" mode.
Arm Title
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Arm Type
Other
Arm Description
Patients with heart failure and SRV and who have a dispositif CRT will be screened for eligibility. If they are eligible and accept to participate (signed informed consent), the order of activation or inactivation of the CRT will be assigned by randomization.Patients randomized into this arm will start the study in "CRT OFF" then "CRT ON" mode.
Intervention Type
Device
Intervention Name(s)
CRT ON (biventricular pacing) / CRT OFF (inactive or univentricular pacing)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CRT OFF (inactive or univentricular pacing) / CRT ON (biventricular pacing)
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
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.
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Secondary Outcome Measure Information:
Title
Peak oxygen uptake
Description
VO2 max (ml/kg/min) during exercise test with standardized protocol,
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
NYHA classification
Description
NYHA classification (class I to IV)
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Right ventricular ejection fraction
Description
Right ventricular ejection fraction assessed by echocardiography (%)
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Tricuspid valve regurgitation
Description
Tricuspid valve regurgitation grade (I to IV) assessed by echocardiography
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
QRS duration
Description
QRS duration measured on electrocardiogram
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Quality of life of patients
Description
Minnesota living with heart failure and SF36v2 questionnaires
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
BNP
Description
BNP level
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Heart failure
Description
Number of hospitalizations for heart failure
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Diuretics
Description
Dose of diuretics prescribed
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Premature cross-over phase termination
Description
Number of patients with need for premature cross-over phase termination to restore previous pacing settings
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
Title
Ventricular arrhythmias
Description
Number of non-sustained and sustained ventricular arrhythmias
Time Frame
Change from the end of the first cross over period (3 months) to the end of the second cross over period (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karine Goude
Phone
+33 1 44 84 17 22
Email
karine.goude@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Le Mao
Phone
+33 1 56 09 54 97
Email
laura.le-mao@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor WADLMANN
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
Hôpital Marie-Lannelongue
City
Le Plessis-Robinson
Country
France
Facility Name
CHU de Lille
City
Lille
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
Hôpital La Timone
City
Marseille
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
AP-HP, Pitié-Salpétrière
City
Paris
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas COMBES
Facility Name
CHU de Tours
City
Tours
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD Sharing Time Frame
Two years after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Learn more about this trial
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
We'll reach out to this number within 24 hrs