ARNI Versus plAcebo in Patients With Congenital sYStemic Right Ventricle Heart Failure (NCT05117736) | Clinical Trial Compass
TerminatedNot Applicable
ARNI Versus plAcebo in Patients With Congenital sYStemic Right Ventricle Heart Failure
Stopped: The trial was prematurely terminated due to safety concerns.
Canada15 participantsStarted 2022-03-15
Plain-language summary
This study is a prospective monocentric, randomized, double-blind, placebo-controlled, crossover clinical trial to assess the efficacy of Sacubitril/Valsartan over placebo in improving exercise capacity and neurohormonal activation in adults with moderate to severe systemic RV dysfunction and NYHA class II or III symptoms.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> or egal18 years with clinical follow-up at the Montreal Heart Institute Adult Congenital Heart Center
* Systemic right ventricle (transposition of great vessels and atrial switch or congenitally corrected transposition of great vessels)
* Moderate to severe systemic right ventricle dysfunction by transthoracic echocardiography (TTE) or right ventricle ejection fraction (RVEF) \<40% by MRI
* NYHA Functional class II-III symptoms or peak exercise capacity \<80% of predicted on a previous standard treadmill exercise stress test (usually done every two years in our congenital clinic).
* Ability to provide informed consent to the study
* Access or own a telephone and/or access to internet connection for teleconference call
* Own a mailing address to receive the medication by post (FedEx or Dicom)
* Able to perform self-measurement of the blood pressure using Upper Arm Digital Blood Pressure Monitor as recommended by Hypertension Canada.
Exclusion Criteria:
* Participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days prior enrolment
* Planned cardiac surgery (e.g., severe tricuspid regurgitation with planned tricuspid valve replacement or repair)
* Previous cardiac transplantation, or on heart transplant wait list
* Myocardial infarction, stroke, or open-heart surgery in the previous 4 weeks
* NYHA Functional class I or IV symptoms
* Symptomatic hypotension (fainting, dizziness, lightheadedness, blurred vis…
What they're measuring
1
Change of sub-maximal total exercise duration
Timeframe: End of each arm treatment at 32 weeks and 58 weeks.
2
Change of NT-proBNP level
Timeframe: End of each arm treatment at 32 weeks and 58 weeks.