A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
CAVS
A Phase II Randomized, Placebo-Controlled, Double-Blinded Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification in Patients With Moderate Calcific Aortic Valve Stenosis
2 other identifiers
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 22, 2021
January 1, 2021
3.1 years
June 23, 2015
August 6, 2019
January 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Aortic Valve Calcium Levels
This will be done using computed tomography (CT) scanning to evaluate aortic valve calcium levels, which is considered to be a "gold standard" for evaluating valvular calcium burden. As measured in Arbitrary Units (AU).
baseline, 6 mos
Secondary Outcomes (5)
Change in Levels of Plasma Interleukin-6
baseline, 6 mos
Change in Aortic Valve Function: Aortic Valve Area
baseline, 6 mos
Change in Left Ventricular Function
baseline, 6 mos
Change in Plasma Tumor Necrosis Factor Alpha
Baseline, 6 months
Change in Aortic Valve Function: Transvalvular Pressure Gradient
baseline, 6 mos
Study Arms (2)
Ataciguat (HMR1766)
EXPERIMENTAL200mg taken daily for 12 months
Matching Placebo
PLACEBO COMPARATORTaken Daily for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 50 years
- Male or female sex
- Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
- Aortic valve calcium levels greater than 300 AU from chest CT
- Ejection fraction \>50%
You may not qualify if:
- Orthostatic intolerance or symptomatic hypotension prior to study or during study visits
- Positive pregnancy test during screening visit
- Nitrate use or α-antagonist medication use within 24 hours
- Systolic blood pressure \<110 mm Hg
- Mean systemic arterial pressure \<75 mm Hg
- Severe mitral or aortic regurgitation
- Retinal or optic nerve problems
- Recent (≤30 days) acute coronary syndrome
- Oxygen saturation \<90% on room air
- Congenital valve disease
- Hepatic dysfunction/elevated liver enzymes
- Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates, etc.)
- Prescription of Warfarin (Coumadin) for chronic anticoagulation
- Concomitant participation in other trials at Mayo Clinic or elsewhere
- Use of phenytoin or related compounds for any indication
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Sanoficollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
Zhang B, Enriquez-Sarano M, Schaff HV, Michelena HI, Roos CM, Hagler MA, Zhang H, Casaclang-Verzosa G, Huang R, Bartoo A, Ranadive S, Joyner MJ, Pislaru S, Nkomo VT, Kremers WK, Araoz PA, Singh G, Walters MA, Hawkinson J, Cunningham KY, Sung J, Dunagan B, Ye Z, Miller JD. Reactivation of Oxidized Soluble Guanylate Cyclase as a Novel Treatment Strategy to Slow Progression of Calcific Aortic Valve Stenosis: Preclinical and Randomized Clinical Trials to Assess Safety and Efficacy. Circulation. 2025 Apr;151(13):913-930. doi: 10.1161/CIRCULATIONAHA.123.066523. Epub 2025 Feb 24.
PMID: 39989354DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jordan D. Miller, Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan D Miller, PhD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SAC II
Study Record Dates
First Submitted
June 23, 2015
First Posted
June 25, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2018
Study Completion
December 1, 2019
Last Updated
January 22, 2021
Results First Posted
January 18, 2020
Record last verified: 2021-01