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Completed

NCT Number: NCT02049203

Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 50 years
  • Male or female sex
  • Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
  • Aortic valve calcium levels greater than 300 arbitrary units from chest CT
  • Ejection fraction >50%

Exclusion criteria

  • History of orthostatic intolerance or symptomatic hypotension
  • Positive pregnancy test during screening visit
  • Nitrate use or α-antagonist medication use within 24 hours
  • Systolic blood pressure <110 mm Hg
  • Mean systemic arterial pressure <75 mm Hg
  • Severe mitral or aortic regurgitation
  • Retinal or optic nerve problems
  • Recent (≤30 days) acute coronary syndrome
  • Oxygen saturation <90% on room air
  • Congenital valve disease
  • Hepatic dysfunction/elevated liver enzymes
  • Prescription of drugs known to alter nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling (sildenafil, nitrates, etc.)
  • History of orthostatic intolerance
  • Concomitant participation in other trials at Mayo Clinic or elsewhere.

Treatment and study plan

Ataciguat

Drug

Other names: HMR1766

Placebo

Drug

Other names: Placebo gel capsule of identical composition to Active group, but does not have active compound.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Subject self-reports of light-headedness/orthostatic intolerance during the standing test and the head-up tilt testing

    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. Evaluating subject perceptions of light-headedness/orthostatic intolerance will help us to understand the relationship between changes in blood pressure and changes in symptoms in this patient population before and after treatment with Ataciguat.

Sponsors and collaborators

Lead sponsor

Jordan D. Miller, Ph.D.

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Center for Research Resources (NCRR)
  • Sanofi-Synthelabo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2014
Registry last updated
Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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