Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension (AcuteAZA)
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Acetazolamide, Hemodynamics
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
Exclusion Criteria:
- 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.
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acetazolamide
Placebo
Arm Description
Diamox 500mg i.v. (1x)
Placebo Saline injection (1x)
Outcomes
Primary Outcome Measures
Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)
At the end of phase at rest
PVR AZA vs. Placebo (exercise)
At the end of phase at exercise
PVR AZA vs. Placebo (hypoxia)
At the end of phase under hypoxia
Secondary Outcome Measures
partial pressure of the oxygen
At the end of each phase (rest, exercise and hypoxia)
Oxygen uptake
minute ventilation
arterial oxygenation
At the end of each phase (rest, exercise and hypoxia)
tissue oxygenation
At the end of each phase (rest, exercise and hypoxia)
mean pulmonary arterial pressure
At the end of each phase (rest, exercise and hypoxia)
cardiac output
At the end of each phase (rest, exercise and hypoxia)
cardiac index
At the end of each phase (rest, exercise and hypoxia)
pulmonary wedge pressure
At the end of each phase (rest, exercise and hypoxia)
Borg scale dyspnea and leg effort
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02755259
Brief Title
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
Acronym
AcuteAZA
Official Title
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (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
To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).
Detailed Description
Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. The investigators have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the acute hemodynamic clinical effects of AZA in PH patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
Acetazolamide, Hemodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
Diamox 500mg i.v. (1x)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Saline injection (1x)
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)
Description
At the end of phase at rest
Time Frame
60 minutes
Title
PVR AZA vs. Placebo (exercise)
Description
At the end of phase at exercise
Time Frame
60 minutes
Title
PVR AZA vs. Placebo (hypoxia)
Description
At the end of phase under hypoxia
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
partial pressure of the oxygen
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
Oxygen uptake
Time Frame
15 minutes
Title
minute ventilation
Time Frame
15 minutes
Title
arterial oxygenation
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
tissue oxygenation
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
mean pulmonary arterial pressure
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
cardiac output
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
cardiac index
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
pulmonary wedge pressure
Description
At the end of each phase (rest, exercise and hypoxia)
Time Frame
60 minutes
Title
Borg scale dyspnea and leg effort
Time Frame
15 minutes
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:
All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, MD
Organizational Affiliation
UniversityHospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34888330
Citation
Duknic M, Lichtblau M, Saxer S, Berlier C, Schneider SR, Schwarz EI, Carta AF, Furian M, Bloch KE, Ulrich S. Comparison of Repetitive Cardiac Output Measurements at Rest and End-Exercise by Direct Fick Using Pulse Oximetry vs. Blood Gases in Patients With Pulmonary Hypertension. Front Med (Lausanne). 2021 Nov 23;8:776956. doi: 10.3389/fmed.2021.776956. eCollection 2021.
Results Reference
derived
Learn more about this trial
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
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