Clinical Trial: Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase Ib Randomized, Placebo-controlled, Double-blinded Study Evaluating the Safety of Ataciguat (HMR1766) in Patients With Moderate Calcific Aortic Valve Stenosis

Brief Summary: 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.

Detailed Summary:
Sponsor: Jordan D. Miller, Ph.D.

Current Primary Outcome:

• Number of patients experiencing orthostatic hypotension [ Time Frame: Baseline - 14 days ]
  The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern.
• The change in blood pressure following the transition from sitting to standing [ Time Frame: Baseline - 14 days ]
  The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Transitioning from sitting to standing is a functional test that will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a relevant orthostatic stress.
• The change in blood pressure following progressive head-up tilt [ Time Frame: Baseline - 14 days ]
  The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Tilt table testing will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a tightly controlled orthostatic stress.
• Subject self-reports of light-headedness/orthostatic intolerance during the standing test and the head-up
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Mayo Clinic
  

  Dates:
  Date Received: January 28, 2014
  Date Started: January 2014
  Date Completion:
  Last Updated: July 5, 2016
  Last Verified: July 2016