Hyperaldosteronism Clinical Trial
— MAPAOfficial title:
Macrolides for KCNJ5 - Mutated Aldosterone-Producing Adenoma (MAPA): A Study Of Personalized Diagnosis of Primary Aldosteronism With Implications For Treatment
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.
Status | Not yet recruiting |
Enrollment | 342 |
Est. completion date | January 2020 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Medicine - DIMED, University of Padova, Italy | Padova |
Lead Sponsor | Collaborator |
---|---|
University Hospital Padova | DMG Paris Descartes |
Italy,
Caroccia B, Prisco S, Seccia TM, Piazza M, Maiolino G, Rossi GP. Macrolides Blunt Aldosterone Biosynthesis: A Proof-of-Concept Study in KCNJ5 Mutated Adenoma Cells Ex Vivo. Hypertension. 2017 Dec;70(6):1238-1242. doi: 10.1161/HYPERTENSIONAHA.117.10226. Epub 2017 Oct 9. — View Citation
Choi M, Scholl UI, Yue P, Björklund P, Zhao B, Nelson-Williams C, Ji W, Cho Y, Patel A, Men CJ, Lolis E, Wisgerhof MV, Geller DS, Mane S, Hellman P, Westin G, Åkerström G, Wang W, Carling T, Lifton RP. K+ channel mutations in adrenal aldosterone-producing adenomas and hereditary hypertension. Science. 2011 Feb 11;331(6018):768-72. doi: 10.1126/science.1198785. — View Citation
Rossi GP, Belfiore A, Bernini G, Desideri G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Montemurro D, Palumbo G, Rizzoni D, Rossi E, Semplicini A, Agabiti-Rosei E, Pessina AC, Mantero F; PAPY Study Investigators. Prospective evaluation of the saline infusion test for excluding primary aldosteronism due to aldosterone-producing adenoma. J Hypertens. 2007 Jul;25(7):1433-42. — View Citation
Rossitto G, Battistel M, Barbiero G, Bisogni V, Maiolino G, Diego M, Seccia TM, Rossi GP. The subtyping of primary aldosteronism by adrenal vein sampling: sequential blood sampling causes factitious lateralization. J Hypertens. 2017 Sep 27. doi: 10.1097/HJH.0000000000001564. [Epub ahead of print] — View Citation
Scholl UI, Abriola L, Zhang C, Reimer EN, Plummer M, Kazmierczak BI, Zhang J, Hoyer D, Merkel JS, Wang W, Lifton RP. Macrolides selectively inhibit mutant KCNJ5 potassium channels that cause aldosterone-producing adenoma. J Clin Invest. 2017 Jun 30;127(7):2739-2750. doi: 10.1172/JCI91733. Epub 2017 Jun 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study 1: Change in Relative Aldosterone Secretion Index (RASI). | Within-patient change from baseline of the RASI in adrenal vein blood draining the gland with and without the APA. | Baseline and after 45min clarithromycin infusion. | |
Primary | Study 2: Change in plasma aldosterone concentration (PAC). | Within-patient change from baseline of PAC in peripheral venous blood in patients undergoing screening for PA. | Baseline and after 60 and 120 minutes roxitromycin administration |
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