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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01812434
Eligibility Criteria:
Inclusion Criteria:
* Subject provided written informed consent
* Subject is 18 years old or Older
* Subject is a cardiac transplant recipient between 6 months - 5 years prior to week 0
Exclusion Criteria:
* Multi-organ transplant
* Been re-transplanted
* A contraindication to taking sildenafil
* Currently taking a PDE-5 inhibitor
* Mean arterial pressure \< 65 mmHg
* A Left ventricular outflow obstruction
* A history or active retinitis pigmentosa
* Major surgery within 3 months of week 0
* Active infections to exclude are (CMV infection, febrile illness and Bacterial illness) within 3 months of week 0
* Acute rejection (grade 3A or greater) within 3 months of week 0
* Chronic kidney disease stage 4 (GFR\<30 mL/min/1.73 m2) or acute renal failure
* Unstable cardiac disease, including myocardial infarction, stroke, or life- threatening arrhythmia within 6 months of week 0
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01812434
Study Brief:
Protocol Section:
NCT01812434