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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)
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
PARACYS-RV Trial 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.
PARACYS-RV Trial 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.
PARACYS-RV Trial 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 morePARACYS-RV Trial 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
120 Previous Clinical Trials
68,804 Total Patients Enrolled
24 Trials studying Heart Failure
10,664 Patients Enrolled for Heart Failure
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,335 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the present scope of individuals enrolled in this clinical experiment?
"Affirmative. The clinicaltrials.gov registry details that this medical trial, which debuted on March 15th 2022, is currently recruiting volunteer participants. 48 individuals are required to be registered from one location only."
Answered by AI
What clinical indications does Sacubitril / Valsartan Oral Tablet typically address?
"Sacubitril / Valsartan Oral Tablet is frequently prescribed to reduce hypesthesia, and can also be used as a primary treatment in the management of cardiovascular mortality and associated events."
Answered by AI
Is this research initiative still open to participants?
"Affirmative. Clinicaltrials.gov has data that confirms this experiment opened for recruitment on March 15th 2022 and was most recently altered on April 4th 2022. The research team is looking to register around 48 individuals from 1 site."
Answered by AI
What previous research has been conducted on Sacubitril / Valsartan Oral Tablet?
"Currently, 58 studies have been conducted concerning Sacubitril / Valsartan Oral Tablet. 12 of those active investigations are in the third phase and numerous trials for this therapeutic option are found in Winston-Salem, North carolina with a total of 915 sites running these experiments."
Answered by AI
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