Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02583906|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep-Disordered Breathing Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension||Device: CPAP||Not Applicable|
The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.
The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
patients randomized to the 'no cpap' arm will not be treated by CPAP
Treatment with CPAP for six months in the CPAP arm.
Other Name: CONTINUOUS POSITIVE AIRWAY PRESSURE
No Intervention: no cpap
patients randomized to the 'cpap' arm will be treated by CPAP
- Change in PVR (pulmonary vascular resistance) [ Time Frame: change in PVR from inclusion at 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583906
|Contact: Catharina Belge, MDPhD||+3216346800|
|Leuven, Belgium, 3000|
|Contact: Catharina Belge +3216346800|
|Principal Investigator: Catharina Belge, MD PhD|
|Principal Investigator:||Catharina Belge, MDPhD||University Hospitals Leuven|