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| Tracking Information | |||||
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| First Received Date ICMJE | September 18, 2007 | ||||
| Last Updated Date | August 28, 2008 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly [ Time Frame: before and after treatment of acromegaly. ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly [ Time Frame: before and after treatment of acromegaly. ] | ||||
| Change History | Complete list of historical versions of study NCT00531908 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Physiopathology of Sodium Retention in Acromegaly | ||||
| Official Title ICMJE | Physiopathology of Sodium Retention in Acromegaly | ||||
| Brief Summary | Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults induces an increase in bone (resulting in large enlargement of extremities), and organs. The disease is complicated by the apparition of cardiovascular events including retention of water, salt in the tissues and increase in blood pressure, that altogether might major the mortality of the patients. The investigators recently got experimental data suggesting that the retention of water and salt is mainly due to the activation by the growth hormone of a renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a well know diuretic, the investigators hypothesize that this drug will be very efficient in treating the hypertension in patients, as compared to another diuretic, furosemide. |
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| Detailed Description | To prove this, we compared the response to amiloride administrated before and after treatment of acromegaly in the same subject. We will also compare the response to furosemide administrated before and after treatment of acromegaly in the same subject. We expected that the response to amiloride will be greater before than after treatment, while the response to furosemide will be lesser before than after treatment. Detailed Description: Definition: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied. Patients will be recruited in the Department of Endocrinology and Reproductive diseases in Bicêtre University Hospital and will be explored in the Centre for Clinical Investigation of HEGP. Investigations will be performed during 4 separate day-hospital stays (2 pre-treatment and 2 post treatment) in the CIC of HEGP. The tests will consist of blood and urine sample collections before and after a single dose administration of furosemide or amiloride. The tests will be performed before treatment of acromegaly in random order and separated by 48hours, interval performed before treatment, and repeated in the same order after normalization of IGF1 by appropriate treatment. The study will last for 2 years, with a 12 months maximal participation of each patient |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Acromegaly | ||||
| Intervention ICMJE | Drug: furosemide | ||||
| Study Arms / Comparison Groups | Experimental: To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly | ||||
| Publications * | Bihan H, Espinosa C, Valdes-Socin H, Salenave S, Young J, Levasseur S, Assayag P, Beckers A, Chanson P. Long-term outcome of patients with acromegaly and congestive heart failure. J Clin Endocrinol Metab. 2004 Nov;89(11):5308-13. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00531908 | ||||
| Responsible Party | Valérie MILLUL, Department of Clinical Research | ||||
| Study ID Numbers ICMJE | P061012, RCB 2007-002619-25 | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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