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

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Institutes of Health (NIH); Sanofi
• Treatments: 5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide

Criteria

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