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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01427192
First received: January 14, 2011
Last updated: December 11, 2012
Last verified: August 2011
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • exercise capacity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Assessment by the 6 minute walk distance

  • Quality of Life [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Assessment by the short form of the SF 36 questionnaire


Secondary Outcome Measures:
  • sleep related breathing disorders [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    assessed by polysomnography according to standard techniques

  • hemodynamics measured by echocardiography [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    right ventricular dimension right ventricular over right atrial pressure

  • venous blood analysis [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    C reactive protein NT-proBNP IL-6

  • Nocturnal oxygen desaturation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Assessed by fingertip puleoxymetry

  • arterial blood analysis [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    oxygenation electrolytes

  • Vigilance [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Assessed by the MURT test


Enrollment: 23
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427192

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

Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01427192     History of Changes
Other Study ID Numbers: CSRPH
Study First Received: January 14, 2011
Last Updated: December 11, 2012
Health Authority: Switzerland: UZurich

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

Additional relevant MeSH terms:
Respiratory Aspiration
Hypertension
Hypertension, Pulmonary
Sleep Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Nervous System Diseases
Neurologic Manifestations
 Mental Disorders
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013