Pulmonary HypertensionPhase 2CSRPHNCT01427192
Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
A Phase 2 study testing acetazolamide, Supplemental oxygen and Non-invasive ventilation in people with Pulmonary Hypertension and Breathing-Related Sleep Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Breathing-Related Sleep Disorder
- What is being tested?
- acetazolamide, Supplemental oxygen and Non-invasive ventilation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Dec 2012
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks
- sleep disordered breathing with apnea/hypopnea index > 10 events/h and/or median nocturnal oxygen saturation <90%
Who cannot join
- Pregnancy
- severe daytime hypoxemia (PaO2 < 7.2 kPA)
- patients with predominantly obstructive sleep apnea.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders
- Trial with medicinal product
- Being tested
- acetazolamide, Supplemental oxygen, Non-invasive ventilation, Room air, Placebo tablet
- Keywords
- Breathing-Related Sleep Disorder, Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
Also called Diamox
250 mg bid
Supplemental oxygenOther
Also called Oxygen concentrator
Oxygen deliverded by nasal cannula
Non-invasive ventilationProcedure or surgery
Bi-level non-invasive ventilation via nasal mask
Room airOther
Room air applied via sham oxygen concentrator
Placebo tabletDrug
Placebo tablet (Mannitol) similar to acetazolamide
| Study group | Role | What they receive |
|---|---|---|
| acetazolamide | Experimental | 1 week therapy, cross-over design Receives: Drug: acetazolamide |
| Placebo tablet | Placebo comparator | One week, cross-over design Receives: Drug: Placebo tablet |
| supplemental oxygen during nights | Experimental | One week, cross-over design Receives: Other: Supplemental oxygen |
| Non-invasive ventilation | Experimental | One week, cross-over design Receives: Procedure: Non-invasive ventilation |
| room air | Sham comparator | room air applied via sham-oxygen-concentrator Receives: Other: Room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
Assessment by the 6 minute walk distance
Measured: 1 week
Quality of Life
Assessment by the short form of the SF 36 questionnaire
Measured: 1 week
Secondary outcomes (6)
sleep related breathing disorders
assessed by polysomnography according to standard techniques
Measured: 1 week
hemodynamics measured by echocardiography
right ventricular dimension right ventricular over right atrial pressure
Measured: 1 week
venous blood analysis
C reactive protein NT-proBNP IL-6
Measured: 1 week
Nocturnal oxygen desaturation
Assessed by fingertip puleoxymetry
Measured: 1 week
arterial blood analysis
oxygenation electrolytes
Measured: 1 week
Vigilance
Assessed by the MURT test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
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 Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427192
- Sponsor's protocol ID
- CSRPH
- Acronym
- CSRPH
- Status last verified
- Aug 2011
- First submitted
- 14 Jan 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-1380. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.
PubMed 18339776Schumacher DS, Muller-Mottet S, Hasler ED, Hildenbrand FF, Keusch S, Speich R, Bloch KE, Ulrich S. Effect of oxygen and acetazolamide on nocturnal cardiac conduction, repolarization, and arrhythmias in precapillary pulmonary hypertension and sleep-disturbed breathing. Chest. 2014 Nov;146(5):1226-1236. doi: 10.1378/chest.14-0495.
PubMed 24991933Ulrich S, Keusch S, Hildenbrand FF, Lo Cascio C, Huber LC, Tanner FC, Speich R, Bloch KE. Effect of nocturnal oxygen and acetazolamide on exercise performance in patients with pre-capillary pulmonary hypertension and sleep-disturbed breathing: randomized, double-blind, cross-over trial. Eur Heart J. 2015 Mar 7;36(10):615-23. doi: 10.1093/eurheartj/eht540. Epub 2013 Dec 23.
PubMed 24366914
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
- ClinicalTrials.gov ID
- NCT01427192
- Acronym / sponsor ID
- CSRPH / CSRPH
- Keywords
- Breathing-Related Sleep Disorder, Pulmonary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Sep 2011 (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 purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| acetazolamide | Experimental | Drug: acetazolamide1 week therapy, cross-over design |
| Placebo tablet | Placebo comparator | Drug: Placebo tabletOne week, cross-over design |
| supplemental oxygen during nights | Experimental | Other: Supplemental oxygenOne week, cross-over design |
| Non-invasive ventilation | Experimental | Procedure: Non-invasive ventilationOne week, cross-over design |
| room air | Sham comparator | Other: Room airroom air applied via sham-oxygen-concentrator |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks
- sleep disordered breathing with apnea/hypopnea index > 10 events/h and/or median nocturnal oxygen saturation <90%
Key exclusion criteria (3 listed)
- Pregnancy
- severe daytime hypoxemia (PaO2 < 7.2 kPA)
- patients with predominantly obstructive sleep apnea.
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 |
|---|---|---|
| acetazolamideAlso: Diamox250 mg bid | Drug | acetazolamide |
| Supplemental oxygenAlso: Oxygen concentratorOxygen deliverded by nasal cannula | Other | supplemental oxygen during nights |
| Non-invasive ventilationBi-level non-invasive ventilation via nasal mask | Procedure or surgery | Non-invasive ventilation |
| Room airRoom air applied via sham oxygen concentrator | Other | room air |
| Placebo tabletPlacebo tablet (Mannitol) similar to acetazolamide | Drug | Placebo tablet |
Primary outcome
exercise capacity
Time frame: 1 week
Assessment by the 6 minute walk distance
Quality of Life
Time frame: 1 week
Assessment by the short form of the SF 36 questionnaire
6 secondary outcomes
sleep related breathing disorders
Time frame: 1 week
hemodynamics measured by echocardiography
Time frame: 1 week
venous blood analysis
Time frame: 1 week
Nocturnal oxygen desaturation
Time frame: 1 week
arterial blood analysis
Time frame: 1 week
Vigilance
Time frame: 1 week
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 12 Dec 2012.
- Background: PubMed 18339776Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-1380. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.
- Derived from this study: PubMed 24991933Schumacher DS, Muller-Mottet S, Hasler ED, Hildenbrand FF, Keusch S, Speich R, Bloch KE, Ulrich S. Effect of oxygen and acetazolamide on nocturnal cardiac conduction, repolarization, and arrhythmias in precapillary pulmonary hypertension and sleep-disturbed breathing. Chest. 2014 Nov;146(5):1226-1236. doi: 10.1378/chest.14-0495.
- Derived from this study: PubMed 24366914Ulrich S, Keusch S, Hildenbrand FF, Lo Cascio C, Huber LC, Tanner FC, Speich R, Bloch KE. Effect of nocturnal oxygen and acetazolamide on exercise performance in patients with pre-capillary pulmonary hypertension and sleep-disturbed breathing: randomized, double-blind, cross-over trial. Eur Heart J. 2015 Mar 7;36(10):615-23. doi: 10.1093/eurheartj/eht540. Epub 2013 Dec 23.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetazolamide, Supplemental oxygen and Non-invasive ventilation in people with Pulmonary Hypertension and Breathing-Related Sleep Disorder, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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 12 Dec 2012. 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
exercise capacity (time frame: 1 week). 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 NCT01427192, 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 12 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.