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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT03414918
Eligibility Criteria:
Inclusion Criteria:
* A signed and dated informed consent form
* A diagnosis of hypertension defined either as:
Use of antihypertensive drug (s) Arterial hypertension: in untreated patients this must be confirmed by daytime ambulatory blood pressure monitoring (ABPM), or home blood pressure monitoring, with blood pressure higher or equal to 135 mmHg for systolic blood pressure and/or higher or equal to 85 mmHg for diastolic blood pressure.
Normal observation of ECG QT interval.
Exclusion Criteria:
* History of allergy/intolerance to any macrolides;
* Refusal of the patient to undergo dynamic testing;
* Refusal of the patient to undergo AVS and/or contraindications to the general anesthesia that is required for laparoscopic adrenalectomy (for objective 2);
* Suspicion of cortisol-aldosterone co-secreting adenoma
* Pregnancy
* Family history of sudden death
* Family history of syncope
* Family history of Long QT syndrome and or torsade de point
* Congenital or drug-induced Long QT syndrome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03414918
Study Brief:
Protocol Section:
NCT03414918