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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiloride, Indometacin, Eplerenone | Experimental | Amiloride, indometacin(+Omeprazole), Eplerenone |
|
| Amiloride, Eplerenone, indometacin | Experimental | Amiloride, Eplerenone, indometacin (+Omeprazole) |
|
| Eplerenone, Amiloride, indometacin | Experimental | Eplerenone, Amiloride, indometacin (+Omeprazole) |
|
| Eplerenone, Indometacin, Amiloride | Experimental | Eplerenone, Indometacin, Amiloride |
|
| Indometacin, Eplerenone, Amiloride | Experimental | Indometacin, Eplerenone, Amiloride |
|
| Indometacin, Amiloride, Eplerenone | Experimental | Indometacin, Amiloride, Eplerenone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREATMENT | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 months | |
| To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blanchard Anne, MD,PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Européen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33107592 | Derived | Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4. |
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| ID | Term |
|---|---|
| D053579 | Gitelman Syndrome |
| D007008 | Hypokalemia |
| ID | Term |
|---|---|
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
|
| 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. | 2 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |