Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo gel capsule, dosage matches number of Ataciguat capsules for each respective dose, capsules taken once daily with breakfast for 14 consecutive days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ataciguat

Ataciguat, orally administered gel capsule, 50, 100, or 200 mg, once per day with breakfast for 14 consecutive days

Group Type ACTIVE_COMPARATOR

Ataciguat

Intervention Type DRUG

Interventions

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Ataciguat

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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HMR1766 Placebo gel capsule of identical composition to Active group, but does not have active compound.

Eligibility Criteria

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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 arbitrary units from chest CT
* Ejection fraction \>50%

Exclusion Criteria

* 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No