A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT02481258
- Phase
- PHASE2
- Status
- Completed
Conditions
- Aortic Valve Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ataciguat (HMR1766) — DRUG
- Placebo Comparator: Matching Placebo — OTHER
Study Details
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.
Key Dates
- Start date
- Jun 30, 2015
- Status verified
- Jan 2021
- Primary completion
- Jul 1, 2018
- Completion
- Dec 1, 2019
Study Design
- Enrollment
- 35 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ataciguat (HMR1766)200mg taken daily for 12 months
- Placebo Comparator: Matching PlaceboTaken Daily for 12 months
Primary Outcome Measure
Changes in Aortic Valve Calcium Levels [ Time Frame: baseline, 6 mos ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
Find similar trials in Rochester, MN
By research site
Related Studies
- PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVRRecruiting · Edwards Lifesciences · Huntsville, Alabama
- ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesRecruiting · Edwards Lifesciences · Newport Beach, California
- Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVRRecruiting · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · San Francisco, California
- ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve ImplantationEnrolling By Invitation · Abbott Medical Devices · Birmingham, Alabama