High Altitude PolycythemiaPhase 4NCT00424970
Treatment of High Altitude Polycythemia by Acetazolamide
A Phase 4 study testing acetazolamide in people with High Altitude Polycythemia, run by Association pour la Recherche en Physiologie de l'Environnement at 1 site in Peru.
Trial summary
The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and 15% in the high altitude regions of South America. There is no pharmacological treatment available. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- High Altitude Polycythemia
- What is being tested?
- acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 sitePeru
- Study dates
- Jan 2007to Nov 2007
- Phase
- Phase 4
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Chronic mountain sickness and Hb > 21g/dl
Who cannot join
- patients smokers
- patients with respiratory or cardiovascular or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and 15% in the high altitude regions of South America. There is no pharmacological treatment available. After a first preliminary study in 2003 demonstrating the beneficial effects of acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want to confirm this effect and implement a treatment protocol of 3 month-duration.
Read the detailed description
Chronic mountain sickness (CMS) is characterized by an excessive number of red cells in the blood of persons living permanently above the altitude of 2,500m. The symptoms of this very incapacitating disease are : headaches, chronic asthenia, digestive troubles, sleep disturbances. The hemoglobin concentration is higher than 21 g/dl of blood. In addition, patients show a pulmonary hypertension of variable degree, as well as a systemic hypertension.
This disease affects essentially males, but women are also concerned after menopause. The evolution of the disease is always very dramatic, towards a cardiac failure and cerebral vascular stroke. The prevalence is between 8% and 15% on the Andean Altiplano . No pharmacological treatment is available.
A preliminary study was performed (Richalet et al. AJRCCM, 2005) that demonstrated the efficiency of acetazolamide (a carbonic anhydrase inhibitor) in reducing the hematocrit and the erythropoetin concentration,and increasing nocturnal oxygen saturation in patients suffering from CMS, after 3 weeks of treatment.
We plan to perform a double-blinded placebo-controlled study to evaluate the efficiency of a 3-month treatment with daily 250 mg acetazolamide to reduce the hematocrit and hemoglobin concentrations and ameliorate the clinical symptoms of 55 patients suffering from CMS and living at high altitude (Cerro de Pasco, Peru).
- Conditions
- High Altitude Polycythemia
- Being tested
- acetazolamide
- Keywords
- high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation
- Medical subject headings
- Altitude Sickness, Hypoxia, Hypertension, Pulmonary, Polycythemia, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
| Study group | Role | What they receive |
|---|---|---|
| acetazolamide | Placebo comparator | acetazolamide 250mg /day oral administration, for 6 months Receives: Drug: acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
Measured: monthly
Hematocrit
Measured: monthly
Secondary outcomes (5)
Systolic pulmonary arterial pressure
Measured: before and after 3 months of treatment
Pulmonary vascular resistance
Measured: before and after 3 months of treatment
Arterial oxygen saturation at rest
Measured: monthly
Clinical score of Chronic Mountain Sickness
Measured: monthly
Quality of lofe score
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJan 2007
- Study completionNov 2007
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 High Altitude PolycythemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche en Physiologie de l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 13, Universidad Peruana Cayetano Heredia, Legs Poix
- Investigators
- Jean-Paul Richalet, MD, PHD, Principal investigator, ARPE, University Paris 13Fabiola Leon-Velarde, PHD, Study director, University Cayetano Heredia, Lima, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424970
- Sponsor's protocol ID
- APCA06
- Other IDs
- Legs Poix 999
- Status last verified
- Jan 2013
- First submitted
- 19 Jan 2007
- Last updated
- 24 Jan 2013
- Results posted
- No
Publications
Richalet JP, Rivera M, Bouchet P, Chirinos E, Onnen I, Petitjean O, Bienvenu A, Lasne F, Moutereau S, Leon-Velarde F. Acetazolamide: a treatment for chronic mountain sickness. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1427-33. doi: 10.1164/rccm.200505-807OC. Epub 2005 Aug 26.
PubMed 16126936Maignan M, Rivera-Ch M, Privat C, Leon-Velarde F, Richalet JP, Pham I. Pulmonary pressure and cardiac function in chronic mountain sickness patients. Chest. 2009 Feb;135(2):499-504. doi: 10.1378/chest.08-1094. Epub 2008 Aug 21.
PubMed 18719057Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, Leon-Velarde F. Acetazolamide for Monge's disease: efficiency and tolerance of 6-month treatment. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1370-6. doi: 10.1164/rccm.200802-196OC. Epub 2008 Apr 3.
PubMed 18388356
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoventilation and High Altitude Chronic Polycythemia: Acetazolamide as a Possible Treatment
- ClinicalTrials.gov ID
- NCT00424970
- Acronym / sponsor ID
- APCA06
- Conditions
- High Altitude Polycythemia
- Keywords
- high altitude, hypoxia, pulmonary hypertension, polycythemia, hypoventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Association pour la Recherche en Physiologie de l'EnvironnementUniversity, hospital or other
- Collaborators
- University of Paris 13, Universidad Peruana Cayetano Heredia, Legs Poix
- Study start
- Jan 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Jan 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.
The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and 15% in the high altitude regions of South America. There is no pharmacological treatment available. After a first preliminary study in 2003 demonstrating the beneficial effects of acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want to confirm this effect and implement a treatment protocol of 3 month-duration.
Detailed description
Chronic mountain sickness (CMS) is characterized by an excessive number of red cells in the blood of persons living permanently above the altitude of 2,500m. The symptoms of this very incapacitating disease are : headaches, chronic asthenia, digestive troubles, sleep disturbances. The hemoglobin concentration is higher than 21 g/dl of blood. In addition, patients show a pulmonary hypertension of variable degree, as well as a systemic hypertension.
This disease affects essentially males, but women are also concerned after menopause. The evolution of the disease is always very dramatic, towards a cardiac failure and cerebral vascular stroke. The prevalence is between 8% and 15% on the Andean Altiplano . No pharmacological treatment is available.
A preliminary study was performed (Richalet et al. AJRCCM, 2005) that demonstrated the efficiency of acetazolamide (a carbonic anhydrase inhibitor) in reducing the hematocrit and the erythropoetin concentration,and increasing nocturnal oxygen saturation in patients suffering from CMS, after 3 weeks of treatment.
We plan to perform a double-blinded placebo-controlled study to evaluate the efficiency of a 3-month treatment with daily 250 mg acetazolamide to reduce the hematocrit and hemoglobin concentrations and ameliorate the clinical symptoms of 55 patients suffering from CMS and living at high altitude (Cerro de Pasco, Peru).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acetazolamide | Placebo comparator | Drug: acetazolamideacetazolamide 250mg /day oral administration, for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with Chronic mountain sickness and Hb > 21g/dl
Key exclusion criteria (2 listed)
- patients smokers
- patients with respiratory or cardiovascular or renal disease
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 |
|---|---|---|
| acetazolamide | Drug | acetazolamide |
Primary outcome
Hemoglobin concentration
Time frame: monthly
Hematocrit
Time frame: monthly
5 secondary outcomes
Systolic pulmonary arterial pressure
Time frame: before and after 3 months of treatment
Pulmonary vascular resistance
Time frame: before and after 3 months of treatment
Arterial oxygen saturation at rest
Time frame: monthly
Clinical score of Chronic Mountain Sickness
Time frame: monthly
Quality of lofe score
Time frame: monthly
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 24 Jan 2013.
- Background: PubMed 16126936Richalet JP, Rivera M, Bouchet P, Chirinos E, Onnen I, Petitjean O, Bienvenu A, Lasne F, Moutereau S, Leon-Velarde F. Acetazolamide: a treatment for chronic mountain sickness. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1427-33. doi: 10.1164/rccm.200505-807OC. Epub 2005 Aug 26.
- Derived from this study: PubMed 18719057Maignan M, Rivera-Ch M, Privat C, Leon-Velarde F, Richalet JP, Pham I. Pulmonary pressure and cardiac function in chronic mountain sickness patients. Chest. 2009 Feb;135(2):499-504. doi: 10.1378/chest.08-1094. Epub 2008 Aug 21.
- Derived from this study: PubMed 18388356Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, Leon-Velarde F. Acetazolamide for Monge's disease: efficiency and tolerance of 6-month treatment. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1370-6. doi: 10.1164/rccm.200802-196OC. Epub 2008 Apr 3.
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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.
Jean-Paul Richalet, MD, PHD principal investigator
ARPE, University Paris 13
Fabiola Leon-Velarde, PHD study director
University Cayetano Heredia, Lima, Peru
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetazolamide in people with High Altitude Polycythemia, run by Association pour la Recherche en Physiologie de l'Environnement at 1 site in Peru.
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 1 inclusion and 2 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 24 Jan 2013. 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 Peru. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemoglobin concentration (time frame: monthly). The study lists 2 primary outcomes in all. 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 NCT00424970, 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 24 Jan 2013.