Safety of Ataciguat in Patients with Moderate Calcific Aortic Valve Stenosis

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jordan Miller, Ph.D.

Closed for enrollment

Contact information:

Maurice Enriquez-Sarano M.D.

(507)266-3626

sarano.maurice@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20144066

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