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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT02611258
Eligibility Criteria:
Inclusion Criteria:
* age\>18 yrs;
* patients (men and women) with previous diagnosis of Cushing Syndrome (CS), surgically and/or clinically treated according to current guidelines, with stable parameters of CS disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic dysfunction developed independently of CS care and detected by 2D echocardiography;
* urinary free cortisol (UFC) levels in the normal range for sex and age;
* normal blood pressure or controlled hypertension
Exclusion Criteria:
* use of thiazolidinediones, or spironolactone; nitrates, doxazosin, terazosin e prazosin;
* current use of PDE5 inhibitors or previous (wash out of two months at least);
* congenital or valvular cardiomyopathy;
* recent ischemic heart disease or revascularization after a myocardial infarction (MI);
* contraindications to tadalafil use (hypersensitivity to tadalafil, nitrates use, severe cardiovascular disorders such as unstable angina or severe heart failure, severe hepatic impairment, blood pressure \<90/50 mmHg, recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa);
* contraindications to CMR.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02611258
Study Brief:
Protocol Section:
NCT02611258