Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
study ends 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 2b/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 in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.

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), 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 ≥1.0 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 Imaging Core Laboratory
  4. For participants on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study

You CAN'T join if...

  1. For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
  2. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
  3. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
  4. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
  5. New York Heart Association (NYHA) Class III or Class IV
  6. Has a primary etiology for heart failure other than aortic valve disease
  7. Has coronary artery disease or anticipating coronary stenting surgery
  8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Locations

  • University of California, San Francisco (UCSF) - Medical Center accepting new patients
    San Francisco California 94143 United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • National Heart Institute accepting new patients
    Beverly Hills California 90211 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Profound Research LLC at Southern California Heart Specialists accepting new patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kardigan, Inc.
ID
NCT07001800
Phase
Phase 2/3 Aortic Stenosis Research Study
Study Type
Interventional
Participants
Expecting 1276 study participants
Last Updated