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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetazolamide | Experimental | 1 week therapy, cross-over design |
|
| Placebo tablet | Placebo Comparator | One week, cross-over design |
|
| supplemental oxygen during nights | Experimental | One week, cross-over design |
|
| Non-invasive ventilation | Experimental | One week, cross-over design |
|
| room air | Sham Comparator | room air applied via sham-oxygen-concentrator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetazolamide | Drug | 250 mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| exercise capacity | Assessment by the 6 minute walk distance | 1 week |
| Quality of Life | Assessment by the short form of the SF 36 questionnaire | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| sleep related breathing disorders | assessed by polysomnography according to standard techniques | 1 week |
| hemodynamics measured by echocardiography | right ventricular dimension right ventricular over right atrial pressure |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinic, University Hospital of Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18339776 | Background | 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. | |
| 24991933 | Derived | Schumacher 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. |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Supplemental oxygen |
| Other |
Oxygen deliverded by nasal cannula |
|
|
| Non-invasive ventilation | Procedure | Bi-level non-invasive ventilation via nasal mask |
|
| Room air | Other | Room air applied via sham oxygen concentrator |
|
| Placebo tablet | Drug | Placebo tablet (Mannitol) similar to acetazolamide |
|
| 1 week |
| venous blood analysis | C reactive protein NT-proBNP IL-6 | 1 week |
| Nocturnal oxygen desaturation | Assessed by fingertip puleoxymetry | 1 week |
| arterial blood analysis | oxygenation electrolytes | 1 week |
| Vigilance | Assessed by the MURT test | 1 week |
| 24366914 | Derived | Ulrich 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. |
| D002318 |
| Cardiovascular Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |