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

Primary Purpose

Pulmonary Hypertension, Breathing-Related Sleep Disorder

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
acetazolamide
Supplemental oxygen
Non-invasive ventilation
Room air
Placebo tablet
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Breathing-Related Sleep Disorder, Pulmonary Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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%

Exclusion criteria:

  • Pregnancy
  • severe daytime hypoxemia (PaO2 < 7.2 kPA)
  • patients with predominantly obstructive sleep apnea.

Sites / Locations

  • Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Sham Comparator

Arm Label

acetazolamide

Placebo tablet

supplemental oxygen during nights

Non-invasive ventilation

room air

Arm Description

1 week therapy, cross-over design

One week, cross-over design

One week, cross-over design

One week, cross-over design

room air applied via sham-oxygen-concentrator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2011
Last Updated
December 11, 2012
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01427192
Brief Title
Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
Acronym
CSRPH
Official Title
Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Breathing-Related Sleep Disorder
Keywords
Breathing-Related Sleep Disorder, Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acetazolamide
Arm Type
Experimental
Arm Description
1 week therapy, cross-over design
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
One week, cross-over design
Arm Title
supplemental oxygen during nights
Arm Type
Experimental
Arm Description
One week, cross-over design
Arm Title
Non-invasive ventilation
Arm Type
Experimental
Arm Description
One week, cross-over design
Arm Title
room air
Arm Type
Sham Comparator
Arm Description
room air applied via sham-oxygen-concentrator
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
250 mg bid
Intervention Type
Other
Intervention Name(s)
Supplemental oxygen
Other Intervention Name(s)
Oxygen concentrator
Intervention Description
Oxygen deliverded by nasal cannula
Intervention Type
Procedure
Intervention Name(s)
Non-invasive ventilation
Intervention Description
Bi-level non-invasive ventilation via nasal mask
Intervention Type
Other
Intervention Name(s)
Room air
Intervention Description
Room air applied via sham oxygen concentrator
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Placebo tablet (Mannitol) similar to acetazolamide
Primary Outcome Measure Information:
Title
exercise capacity
Description
Assessment by the 6 minute walk distance
Time Frame
1 week
Title
Quality of Life
Description
Assessment by the short form of the SF 36 questionnaire
Time Frame
1 week
Secondary Outcome Measure Information:
Title
sleep related breathing disorders
Description
assessed by polysomnography according to standard techniques
Time Frame
1 week
Title
hemodynamics measured by echocardiography
Description
right ventricular dimension right ventricular over right atrial pressure
Time Frame
1 week
Title
venous blood analysis
Description
C reactive protein NT-proBNP IL-6
Time Frame
1 week
Title
Nocturnal oxygen desaturation
Description
Assessed by fingertip puleoxymetry
Time Frame
1 week
Title
arterial blood analysis
Description
oxygenation electrolytes
Time Frame
1 week
Title
Vigilance
Description
Assessed by the MURT test
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18339776
Citation
Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-1380. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.
Results Reference
background
PubMed Identifier
24991933
Citation
Schumacher DS, Muller-Mottet S, Hasler ED, Hildenbrand FF, Keusch S, Speich R, Bloch KE, Ulrich S. Effect of oxygen and acetazolamide on nocturnal cardiac conduction, repolarization, and arrhythmias in precapillary pulmonary hypertension and sleep-disturbed breathing. Chest. 2014 Nov;146(5):1226-1236. doi: 10.1378/chest.14-0495.
Results Reference
derived
PubMed Identifier
24366914
Citation
Ulrich S, Keusch S, Hildenbrand FF, Lo Cascio C, Huber LC, Tanner FC, Speich R, Bloch KE. Effect of nocturnal oxygen and acetazolamide on exercise performance in patients with pre-capillary pulmonary hypertension and sleep-disturbed breathing: randomized, double-blind, cross-over trial. Eur Heart J. 2015 Mar 7;36(10):615-23. doi: 10.1093/eurheartj/eht540. Epub 2013 Dec 23.
Results Reference
derived

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Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

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