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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01427192

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension Breathing-Related Sleep Disorder	Drug: acetazolamide Other: Supplemental oxygen Procedure: Non-invasive ventilation Other: Room air Drug: Placebo tablet	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acetazolamide 1 week therapy, cross-over design	Drug: acetazolamide 250 mg bid Other Names: Diamox
Placebo Comparator: Placebo tablet One week, cross-over design	Drug: Placebo tablet Placebo tablet (Mannitol) similar to acetazolamide
Experimental: supplemental oxygen during nights One week, cross-over design	Other: Supplemental oxygen Oxygen deliverded by nasal cannula Other Names: Oxygen concentrator
Experimental: Non-invasive ventilation One week, cross-over design	Procedure: Non-invasive ventilation Bi-level non-invasive ventilation via nasal mask
Sham Comparator: room air room air applied via sham-oxygen-concentrator	Other: Room air Room air applied via sham oxygen concentrator

Outcome Measures

Primary Outcome Measures

exercise capacity [1 week]
Assessment by the 6 minute walk distance
Quality of Life [1 week]
Assessment by the short form of the SF 36 questionnaire

Secondary Outcome Measures

sleep related breathing disorders [1 week]
assessed by polysomnography according to standard techniques
hemodynamics measured by echocardiography [1 week]
right ventricular dimension right ventricular over right atrial pressure
venous blood analysis [1 week]
C reactive protein NT-proBNP IL-6
Nocturnal oxygen desaturation [1 week]
Assessed by fingertip puleoxymetry
arterial blood analysis [1 week]
oxygenation electrolytes
Vigilance [1 week]
Assessed by the MURT test

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%