Your session is about to expire
← Back to Search
Angiotensin Receptor-Neprilysin Inhibitor
ARNI for Systemic Right Ventricle Heart Failure (PARACYS-RV Trial)
N/A
Waitlist Available
Led By Marie-A. Chaix, MD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe systemic right ventricle dysfunction by transthoracic echocardiography (TTE) or right ventricle ejection fraction (RVEF) <40% by MRI
Systemic right ventricle (transposition of great vessels and atrial switch or congenitally corrected transposition of great vessels)
Must not have
NYHA Functional class I or IV symptoms
Symptomatic hypotension (fainting, dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache) with a systolic blood pressure <100 mmHg at screening, or asymptomatic <90 mmHg at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up half-way of each arm at 20 and 46 weeks and end of each arm treatment at 32 weeks and 58 weeks.
Awards & highlights
Summary
This trial is testing whether a new drug, Sacubitril/Valsartan, is better than placebo at improving exercise capacity and reducing neurohormonal activation in people with moderate to severe RV dysfunction.
Who is the study for?
Adults over 18 with moderate to severe systemic right ventricle dysfunction and NYHA class II or III heart failure symptoms, who can consent, have internet/phone access, a mailing address for medication delivery, and can self-measure blood pressure. Excludes those in other drug trials recently, planned cardiac surgery or transplant candidates, certain kidney/liver issues, history of angioedema with ACEI/ARB therapy, symptomatic hypotension.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Sacubitril/Valsartan tablets compared to placebo in improving exercise capacity and reducing neurohormonal activation in patients with systemic right ventricle heart failure. It's a double-blind study where neither participants nor researchers know who receives the real medicine versus placebo.See study design
What are the potential side effects?
Potential side effects include allergic reactions like angioedema (swelling under the skin), changes in kidney function including increased potassium levels which could be dangerous if too high; low blood pressure that might cause fainting or dizziness; liver problems indicated by abnormal blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's right side is not pumping well, confirmed by an echo or MRI.
Select...
My heart's main pumping chamber is on the right side due to a congenital condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart condition causes no or severe limitations.
Select...
I experience symptoms like fainting or dizziness with low blood pressure.
Select...
My kidney function is severely reduced.
Select...
My liver tests are higher than normal.
Select...
I am taking medication for conditions other than heart failure.
Select...
I have narrowing in the arteries of both my kidneys.
Select...
I have severe heart valve issues or blood flow problems.
Select...
I am scheduled for heart surgery, such as tricuspid valve repair.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ half-way of each arm at 20 and 46 weeks and end of each arm treatment at 32 weeks and 58 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~half-way of each arm at 20 and 46 weeks and end of each arm treatment at 32 weeks and 58 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of NT-proBNP level
Change of sub-maximal total exercise duration
Secondary outcome measures
Change of number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Change of quality of life measured by Kansas City Cardiomyopathy Questionnaire-12 Score
Other outcome measures
Change of NYHA functional class
Change of cardiopulmonary exercise test
Change of hs troponin-T level
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention
Treatment with Sacubitril/Valsartan
Group II: PlaceboPlacebo Group1 Intervention
Treatment with Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacubitril / Valsartan Oral Tablet
2022
Completed Phase 4
~280
Find a Location
Who is running the clinical trial?
Montreal Heart InstituteLead Sponsor
122 Previous Clinical Trials
78,745 Total Patients Enrolled
24 Trials studying Heart Failure
10,449 Patients Enrolled for Heart Failure
Novartis PharmaceuticalsIndustry Sponsor
2,874 Previous Clinical Trials
4,199,976 Total Patients Enrolled
68 Trials studying Heart Failure
2,001,697 Patients Enrolled for Heart Failure
Marie-A. Chaix, MDPrincipal InvestigatorMontreal Heart Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition causes no or severe limitations.I have not had a heart attack, stroke, or open-heart surgery in the last 4 weeks.My heart function is moderately affected, or my exercise capacity is less than 80% of what's expected.You have had a heart transplant in the past or are currently waiting for a heart transplant.I experience symptoms like fainting or dizziness with low blood pressure.My kidney function is severely reduced.Your potassium levels are too high.My liver tests are higher than normal.I am taking medication for conditions other than heart failure.My heart's right side is not pumping well, confirmed by an echo or MRI.I am 18 or older and receive care at the Montreal Heart Institute.You have very high pressure in your lungs, which is equal to or higher than the pressure in the rest of your body.You had bad reactions to ACE-inhibitors or ARBs.I have narrowing in the arteries of both my kidneys.I have severe heart valve issues or blood flow problems.My heart's main pumping chamber is on the right side due to a congenital condition.Your kidney function has decreased by more than 35% from the initial screening to the randomization.You have had swelling in the past related to certain blood pressure medications, or have a history of unexplained swelling.I am scheduled for heart surgery, such as tricuspid valve repair.You are not able to do physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Sacubitril/Valsartan
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger