Clinical Trial: Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome

Brief Summary: Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

Detailed Summary: Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [ Time Frame: 2 months ]

Original Primary Outcome: Treatment-induced increased in plasma potassium concentration at the end of each two month treatment period [ Time Frame: 2 months ]

Current Secondary Outcome:

  • To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio) [ Time Frame: 2 months ]
  • To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. [ Time Frame: 2 months ]
  • To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders [ Time Frame: 2 months ]
    To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders other than hypokalemia (hypomagnesemia, hyperaldosteronism), glomerular filtration rate, hypotension, clinical tolerance, and quality of life.


Original Secondary Outcome: Treatment-induced increased in plasma magnesium concentration at the end of each two month treatment period, EKG modifications, quality of life improvement [ Time Frame: 2 months ]

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: June 16, 2010
Date Started: February 2010
Date Completion:
Last Updated: December 9, 2013
Last Verified: December 2009