Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT02049203
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02049203
Study Brief:
Protocol Section:
NCT02049203