Physiopathology of Sodium Retention in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Physiopathology of Sodium Retention in Acromegaly

Official Title

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.

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
      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

Study Type

Interventional

Primary Outcome

To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly

Secondary Outcome

 To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegaly

Condition

Acromegaly

Intervention

furosemide

Study Arms / Comparison Groups

 A
Description:  To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

12

Start Date

September 2007

Completion Date

December 2009

Primary Completion Date

December 2009

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Peter KAMENICKY, MD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00531908

Organization ID

P061012

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Institut National de la Santé Et de la Recherche Médicale, France

Study Sponsor

Peter KAMENICKY, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris

Verification Date

August 2008