Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rochester, Minnesota 55905


Purpose:

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.


Study summary:

Patients with Moderate Calcific Aortic Valve Stenosis may be eligible for enrollment in this study. Participation lasts 12 months, which includes a total of 3 study visits (baseline/screening visit, 6 month follow up visit and 12 month follow up visit). During each visit, a blood sample will be taken along with other research related tests (Orthostatic Tolerance Standing Test, CT Scan, Echocardiogram, DEXA Scan). Qualifying Participants will be supplied with 6 months worth of study medication or placebo during visits 1 (baseline/screening visit) and 2 (6 month follow up visit) in which they will take at home daily with food. On visit 3 (12 month follow up visit), any remaining study medication or placebo will be returned to study staff.


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


NCT ID:

NCT02481258


Primary Contact:

Principal Investigator
Jordan D Miller, PhD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.