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

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. Read our disclaimer for details. Identifier: NCT01427192
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):
University of Zurich

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 Type : Interventional  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: acetazolamide
1 week therapy, cross-over design
Drug: acetazolamide
250 mg bid
Other Name: 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 Name: 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

Primary Outcome Measures :
  1. exercise capacity [ Time Frame: 1 week ]
    Assessment by the 6 minute walk distance

  2. Quality of Life [ Time Frame: 1 week ]
    Assessment by the short form of the SF 36 questionnaire

Secondary Outcome Measures :
  1. sleep related breathing disorders [ Time Frame: 1 week ]
    assessed by polysomnography according to standard techniques

  2. hemodynamics measured by echocardiography [ Time Frame: 1 week ]
    right ventricular dimension right ventricular over right atrial pressure

  3. venous blood analysis [ Time Frame: 1 week ]
    C reactive protein NT-proBNP IL-6

  4. Nocturnal oxygen desaturation [ Time Frame: 1 week ]
    Assessed by fingertip puleoxymetry

  5. arterial blood analysis [ Time Frame: 1 week ]
    oxygenation electrolytes

  6. Vigilance [ Time Frame: 1 week ]
    Assessed by the MURT test

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01427192

Respiratory Clinic, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Zurich Identifier: NCT01427192     History of Changes
Other Study ID Numbers: CSRPH
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: August 2011

Keywords provided by University of Zurich:
Breathing-Related Sleep Disorder
Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Respiratory Aspiration
Sleep Wake Disorders
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs