CompletedPhase 2

A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

United States35 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. 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%

Exclusion criteria

✕. 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

What they're measuring

Changes in Aortic Valve Calcium Levels

Timeframe: baseline, 6 mos

Trial details

NCT IDNCT02481258

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-01

Results submitted2019-08-06

View on ClinicalTrials.gov More Aortic Valve Stenosis trials