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

Completed · Phase 2 · Has a placebo group

Conditions studied: Aortic Valve Stenosis

In brief

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 facts

Study ID

NCT02481258

Run by

Mayo Clinic

People needed

35

Starts

2015-06-01

Expected to finish

2019-12-01

Last updated by the study team

2021-01-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
• Chronic midazolam treatment for any indication
• Use of monoamine oxidase inhibitors for any indication
• Use of anti-diabetic drugs in the sulfonylurea family

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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