Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA)

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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; 2) the change of PAC in response to mutated KCNJ5 channel is truly occurring in KCNJ5-mutated APA.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Padova
• Collaborator: DMG Paris Descartes
• Treatments: Clarithromycin; Roxithromycin

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