RECRUITING

A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis

Description

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Conditions

Moderate Aortic Valve Stenosis
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Related Conditions:

Moderate Aortic Valve Stenosis

Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

A Phase 3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis

A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis

Condition
Moderate Aortic Valve Stenosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) - Medical Center, Birmingham, Alabama, United States, 35233

Huntsville

Heart Center Research LLC, Huntsville, Alabama, United States, 35801

Beverly Hills

National Heart Institute, Beverly Hills, California, United States, 90211

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Pasadena

Profound Research LLC at Southern California Heart Specialists, Pasadena, California, United States, 91105

San Francisco

University of California, San Francisco (UCSF) - Medical Center, San Francisco, California, United States, 94143

Torrance

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Torrance, California, United States, 90502

Atlantis

HCA Florida - JFK Hospital, Atlantis, Florida, United States, 33462

Hialeah

New Generation of Medical Research, Hialeah, Florida, United States, 33016

Naples

New Generation of Medical Research - Naples, Naples, Florida, United States, 34116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adult male or female at least 50 years of age
  • 2. Has moderate CAVS as defined by:
  • 1. An AVA of ≥1 cm2 to ≤1.50 cm2
  • 2. An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men
  • 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Core Laboratory
  • 4. Can perform Cardiopulmonary Exercise Testing (CPET)
  • 1. Has had a prior aortic valve replacement, repair, surgery, or intervention
  • 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
  • 3. Has known congenital aortic valve disease including bicuspid aortic valve
  • 4. New York Heart Association (NYHA) Class III or Class IV
  • 5. Has heart failure such as cardiomyopathy, congenital heart disease, myocarditis
  • 6. Has coronary artery disease or anticipating coronary stenting surgery
  • 7. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kardigan, Inc.,

Study Record Dates

2030-09-30