Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

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

Details

This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition and whether the change in AVC effects peak oxygen consumption (pVO2) in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. The purpose of Part B is to evaluate the effect of ataciguat on peak VO2 and to investigate whether ataciguat reduces the rate of aortic valve area (AVA) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated.

Keywords

Moderate Aortic Valve Stenosis, Ataciguat, sGC activator, sGC stimulator, Aortic valve stenosis, Calcific aortic valve stenosis, CAVS, Moderate Calcific Aortic Valve Stenosis, Aortic Stenosis (AS), Pathologic Constriction, 5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide

Eligibility

You can join if…

Open to people ages 50 years and up

  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)

You CAN'T join if...

  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

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
    Torrance California 90502 United States
  • National Heart Institute
    Beverly Hills California 90211 United States
  • Profound Research LLC at Southern California Heart Specialists
    Pasadena California 91105 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Kardigan, Inc.
ID
NCT07001800
Phase
Phase 3 Aortic Stenosis Research Study
Study Type
Interventional
Participants
Expecting 1410 study participants
Last Updated