Status:
UNKNOWN
Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)
Lead Sponsor:
University Hospital Padova
Collaborating Sponsors:
DMG Paris Descartes
Conditions:
Hyperaldosteronism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study evaluates if : 1 ) the plasma aldosterone concentration and blood pressure change in response to roxithromycin could be useful for the screening of PA patients carrying a KCNJ5-mutated APA...
Detailed Description
Aldosterone-producing adenoma (APA) cause primary aldosteronism (PA), the main curable cause of endocrine hypertension, is in up to 66% of all cases investigated with adrenal vein sampling (AVS). Muta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT03414918
Start Date
March 1 2018
End Date
January 1 2020
Last Update
January 30 2018
Active Locations (1)
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1
Department of Medicine - DIMED, University of Padova, Italy
Padua, Italy