NCT01427192

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 12, 2012

Status Verified

August 1, 2011

Enrollment Period

2.1 years

First QC Date

January 14, 2011

Last Update Submit

December 11, 2012

Conditions

Pulmonary HypertensionBreathing-Related Sleep Disorder

Keywords

Breathing-Related Sleep DisorderPulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

  • exercise capacity

    Assessment by the 6 minute walk distance

    1 week

  • Quality of Life

    Assessment by the short form of the SF 36 questionnaire

    1 week

Secondary Outcomes (6)

  • sleep related breathing disorders

    1 week

  • hemodynamics measured by echocardiography

    1 week

  • venous blood analysis

    1 week

  • Nocturnal oxygen desaturation

    1 week

  • arterial blood analysis

    1 week

  • +1 more secondary outcomes

Study Arms (5)

acetazolamide

EXPERIMENTAL

1 week therapy, cross-over design

Drug: acetazolamide

Placebo tablet

PLACEBO COMPARATOR

One week, cross-over design

Drug: Placebo tablet

supplemental oxygen during nights

EXPERIMENTAL

One week, cross-over design

Other: Supplemental oxygen

Non-invasive ventilation

EXPERIMENTAL

One week, cross-over design

Procedure: Non-invasive ventilation

room air

SHAM COMPARATOR

room air applied via sham-oxygen-concentrator

Other: Room air

Interventions

acetazolamideDRUG

250 mg bid

Also known as: Diamox
acetazolamide
Supplemental oxygenOTHER

Oxygen deliverded by nasal cannula

Also known as: Oxygen concentrator
supplemental oxygen during nights
Non-invasive ventilationPROCEDURE

Bi-level non-invasive ventilation via nasal mask

Non-invasive ventilation
Room airOTHER

Room air applied via sham oxygen concentrator

room air
Placebo tabletDRUG

Placebo tablet (Mannitol) similar to acetazolamide

Placebo tablet

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 18339776BACKGROUND

  • 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.

    PMID: 24991933DERIVED

  • 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.

    PMID: 24366914DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

AcetazolamideNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

September 1, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 12, 2012

Record last verified: 2011-08

Locations

CH(1)