Chronic Clinical Effect of Acetazolamide
ChronicAZA
1 other identifier
interventional
24
1 country
1
Brief Summary
The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedDecember 19, 2020
December 1, 2020
4.1 years
March 24, 2016
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in 6 min walk distance
At the end of both periods (AZA and Placebo)
5 weeks
Secondary Outcomes (14)
Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF)
5 weeks
Progressive maximal ramp cardiopulmonary exercise testing
5 weeks
cerebral and muscle tissue oxygenation
5 weeks
daily activity
5 weeks
morphological and functional parameters of the heart
5 weeks
- +9 more secondary outcomes
Study Arms (2)
Acetazolamide
EXPERIMENTALTwice a day 250 mg acetazolamide for 5 weeks
Placebo
PLACEBO COMPARATORPlacebo capsule 250 mg (Mannitol) twice a day 5 weeks
Interventions
Eligibility Criteria
You may qualify if:
- All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
- Patients have to be in a stable condition, on the same medication for \>4 weeks
You may not qualify if:
- Patients in whom a RHC is clinically not indicated
- pregnant women
- PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
Related Publications (1)
Lichtblau M, Saxer S, Muller J, Appenzeller P, Berlier C, Schneider SR, Mayer L, Furian M, Schwarz EI, Swenson ER, Bloch KE, Ulrich S. Effect of 5 weeks of oral acetazolamide on patients with pulmonary vascular disease: A randomized, double-blind, cross-over trial. Pulmonology. 2024 Jul-Aug;30(4):362-369. doi: 10.1016/j.pulmoe.2022.11.004. Epub 2023 Jan 11.
PMID: 36639329DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Ulrich, MD
UniversityHospital Zurich
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 28, 2016
Study Start
October 1, 2016
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
December 19, 2020
Record last verified: 2020-12