NCT00531908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 7, 2011

Status Verified

August 1, 2008

Enrollment Period

2.3 years

First QC Date

September 18, 2007

Last Update Submit

December 6, 2011

Conditions

Acromegaly

Keywords

Growth HormoneEpithelial sodium channelHypertensionA FurosemideNasal Mucosa

Outcome Measures

Primary Outcomes (1)

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

    before and after treatment of acromegaly.

Secondary Outcomes (2)

  • 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.

  • To study the difference of the intranasal potential

    before and after treatment of acromegaly.

Study Arms (1)

A

EXPERIMENTAL

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

Drug: furosemide

Interventions

furosemideDRUG

furosemide

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Bicetre

Paris, 75000, France

Location

Related Publications (3)

  • 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. doi: 10.1210/jc.2004-0821.

    PMID: 15531475RESULT

  • Kamenicky P, Blanchard A, Gauci C, Salenave S, Letierce A, Lombes M, Brailly-Tabard S, Azizi M, Prie D, Souberbielle JC, Chanson P. Pathophysiology of renal calcium handling in acromegaly: what lies behind hypercalciuria? J Clin Endocrinol Metab. 2012 Jun;97(6):2124-33. doi: 10.1210/jc.2011-3188. Epub 2012 Apr 10.

    PMID: 22496496DERIVED

  • Kamenicky P, Blanchard A, Frank M, Salenave S, Letierce A, Azizi M, Lombes M, Chanson P. Body fluid expansion in acromegaly is related to enhanced epithelial sodium channel (ENaC) activity. J Clin Endocrinol Metab. 2011 Jul;96(7):2127-35. doi: 10.1210/jc.2011-0078. Epub 2011 Apr 20.

    PMID: 21508131DERIVED

MeSH Terms

Conditions

AcromegalyHypertension

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Peter KAMENICKY, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 7, 2011

Record last verified: 2008-08

Locations

FR(1)