Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— CSRPH  

Official title:

Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427192
• Other study ID #: CSRPH
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2011
• Last updated: December 11, 2012
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: UZurich
• Study type: Interventional

Clinical 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

• Trial with medicinal product

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria:

• 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%

Exclusion criteria:

• Pregnancy

• severe daytime hypoxemia (PaO2 < 7.2 kPA)

• patients with predominantly obstructive sleep apnea.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breathing-Related Sleep Disorder
• Hypertension
• Hypertension, Pulmonary
• Parasomnias
• Pulmonary Hypertension
• Respiratory Aspiration
• Sleep Disorders

Intervention

Drug:
• acetazolamide
250 mg bid

Other:
• Supplemental oxygen
Oxygen deliverded by nasal cannula

Procedure:
• Non-invasive ventilation
Bi-level non-invasive ventilation via nasal mask

Other:
• Room air
Room air applied via sham oxygen concentrator

Drug:
• Placebo tablet
Placebo tablet (Mannitol) similar to acetazolamide

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-80. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity	Assessment by the 6 minute walk distance	1 week	No
Primary	Quality of Life	Assessment by the short form of the SF 36 questionnaire	1 week	No
Secondary	sleep related breathing disorders	assessed by polysomnography according to standard techniques	1 week	No
Secondary	hemodynamics measured by echocardiography	right ventricular dimension right ventricular over right atrial pressure	1 week	No
Secondary	venous blood analysis	C reactive protein NT-proBNP IL-6	1 week	Yes
Secondary	Nocturnal oxygen desaturation	Assessed by fingertip puleoxymetry	1 week	Yes
Secondary	arterial blood analysis	oxygenation electrolytes	1 week	Yes
Secondary	Vigilance	Assessed by the MURT test	1 week	Yes