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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT02481258
Phase
PHASE2
Status
Completed

Conditions

  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Jan 2021
Primary completion
Jul 1, 2018
Completion
Dec 1, 2019

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ataciguat (HMR1766)
    200mg taken daily for 12 months
  • Placebo Comparator: Matching Placebo
    Taken Daily for 12 months

Primary Outcome Measure

Changes in Aortic Valve Calcium Levels [ Time Frame: baseline, 6 mos ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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