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

Overview

About this study

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.

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

  1. Age > 50 years
  2. Male or female sex
  3. Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
  4. Aortic valve calcium levels greater than 300 AU from chest CT
  5. Ejection fraction >50%

Exclusion Criteria

  1. Orthostatic intolerance or symptomatic hypotension prior to study or during study visits
  2. Positive pregnancy test during screening visit
  3. Nitrate use or α-antagonist medication use within 24 hours
  4. Systolic blood pressure <110 mm Hg
  5. Mean systemic arterial pressure <75 mm Hg
  6. Severe mitral or aortic regurgitation
  7. Retinal or optic nerve problems
  8. Recent (≤30 days) acute coronary syndrome
  9. Oxygen saturation <90% on room air
  10. Congenital valve disease
  11. Hepatic dysfunction/elevated liver enzymes
  12. Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates, etc.)
  13. Prescription of Warfarin (Coumadin) for chronic anticoagulation
  14. Concomitant participation in other trials at Mayo Clinic or elsewhere
  15. Use of phenytoin or related compounds for any indication
  16. Chronic midazolam treatment for any indication
  17. Use of monoamine oxidase inhibitors for any indication
  18. Use of anti-diabetic drugs in the sulfonylurea family

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:

Brandon Dunagan CCRP

(507)255-7566

Dunagan.Brandon@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-20146640

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