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

Assistance Publique - Hôpitaux de Paris33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gitelman Syndrome

Interventions

TREATMENTDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman. Exclusion Criteria: * counter-indication to treatment under study * Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin

Locations (1)

Hopital Européen Georges Pompidou

Paris, France

Outcomes

Primary Outcomes

To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone

Time frame: 2 months

Secondary Outcomes

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

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.

Time frame: 2 months

Data from ClinicalTrials.gov

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