Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Aortic Valve Stenosis

In brief

This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.

Key facts

Study ID

NCT02049203

Run by

Jordan D. Miller, Ph.D.

People needed

44

Starts

2014-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-07-07

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 arbitrary units from chest CT
• Ejection fraction >50%

You may not qualify if…

• History of orthostatic intolerance or symptomatic hypotension
• 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 nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling (sildenafil, nitrates, etc.)
• History of orthostatic intolerance
• Concomitant participation in other trials at Mayo Clinic or elsewhere.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.