Physiopathology of Sodium Retention in Acromegaly

Acromegaly Clinical Trial

— AcromEnaC  

Official title:

Physiopathology of Sodium Retention in Acromegaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531908
• Other study ID #: P061012
• Status: Completed
• Phase: N/A
• First received: September 18, 2007
• Last updated: December 6, 2011
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 BICETRE 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18 to 75 yrs

• proven evolutive acromegalia with indication of treatment (surgical or medical)

• controlled blood pressure (systolic BP < 140 mmHg et diastolic BP < 90 mmHg)

• signed informed consent

• efficient contraception in women

Exclusion Criteria:

• edematous state unrelated to acromegaly

• history of sulfamide intolerance

• hemoglobin < 8g/dL

• pregnant or breastfeeding women

• inability to give informed consent

• blood donation in the preceding 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly
• Hypernatremia

Intervention

Drug:
• furosemide
furosemide

Locations

Country	Name	City	State
France	Hopital Bicetre	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly		before and after treatment of acromegaly.	Yes
Secondary	To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegaly		before and after treatment of acromegaly.	Yes
Secondary	To study the difference of the intranasal potential		before and after treatment of acromegaly.	Yes