Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB (REVERSE-AR)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    100
  • sponsor
    Samsung Medical Center
Send
Updated on 23 March 2022
See if I qualify
ejection fraction
regurgitation

Summary

The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.

Description

After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.

Details
Condition Aortic Valve Insufficiency
Treatment Sacubitril-Valsartan, Amlodipine-losartan
Clinical Study IdentifierNCT05212597
SponsorSamsung Medical Center
Last Modified on23 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant over 20 years of age who has not been hospitalized for heart failure
Participant with hypertension or systolic blood pressure 125 mmHg or higher
NYHA I
Participant with chronic severe aortic regurgitation (VCW >0.6cm)
Participant with AV regurgitant volume ≥ 60mL or effective regurgitant orifice area ≥ 0.3 cm2
Participant with left ventricular ejection fraction ≥ 55%

Exclusion Criteria

A history of hypersensitivity or allergy to clinical trial drugs or similar compounds or ARB/NEP inhibitors
History of angioedema
Patients with an ascending aorta dilated by more than 55 mm
Patients with aortic valve insufficiency due to hereditary aortic disease (Marfan syndrome, Ehlers-Danlos syndrome)
Patients with moderate to severe aortic stenosis
Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
History of acute heart failure within 6 weeks and dyspnea of NYHA II or higher
Symptomatic hypotension or SBP < 100 mmHg at screening
Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis
Significant increase in blood potassium level (Potassium > 5 mmol/L)
Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneous coronary angioplasty within 3 months
If aortic valve surgery is scheduled within the next 6 months
In case of severe mitral valve disease
Patients with primary hyperaldosteronism
If a woman of childbearing potential has not used double contraception
Women who are currently pregnant or lactating
When it is judged that there are clinically significant abnormalities in physical examination, diagnostic examination, electrocardiogram, etc. at the time of the screening visit
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

ejection fraction
regurgitation

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note