Safety of Ataciguat in Patients with Moderate Calcific Aortic Valve Stenosis
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-005387
NCT ID: NCT02049203
Sponsor Protocol Number: 13-005387
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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%
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.