AcromegalyAcromEnaCNCT00531908
Physiopathology of Sodium Retention in Acromegaly
A study testing furosemide in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Acromegaly
- Being tested
- furosemide
- Keywords
- Growth Hormone, Epithelial sodium channel, Hypertension, A Furosemide, Nasal Mucosa
- Medical subject headings
- Acromegaly, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
furosemide
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly Receives: Drug: furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly
Measured: 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
Measured: before and after treatment of acromegaly.
To study the difference of the intranasal potential
Measured: before and after treatment of acromegaly.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter KAMENICKY, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531908
- Sponsor's protocol ID
- P061012
- Acronym
- AcromEnaC
- Status last verified
- Aug 2008
- First submitted
- 18 Sep 2007
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1210/jc.2004-0821.
PubMed 15531475Kamenicky 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.
PubMed 22496496Kamenicky 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.
PubMed 21508131
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Sodium Retention in Acromegaly
- ClinicalTrials.gov ID
- NCT00531908
- Acronym / sponsor ID
- AcromEnaC / P061012
- Conditions
- Acromegaly
- Keywords
- Growth Hormone, Epithelial sodium channel, Hypertension, A Furosemide, Nasal Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: furosemideTo compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- edematous state unrelated to acromegaly
- history of sulfamide intolerance
- hemoglobin < 8g/dL
- pregnant or breastfeeding women
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| furosemidefurosemide | Drug | A |
Primary outcome
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.
2 secondary outcomes
To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegaly
Time frame: before and after treatment of acromegaly.
To study the difference of the intranasal potential
Time frame: before and after treatment of acromegaly.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- Results publication: PubMed 15531475Bihan 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.
- Derived from this study: PubMed 22496496Kamenicky 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.
- Derived from this study: PubMed 21508131Kamenicky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter KAMENICKY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing furosemide in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00531908, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.