NCT02755259

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

March 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

March 24, 2016

Last Update Submit

August 12, 2019

Conditions

Hypertension, Pulmonary

Keywords

AcetazolamideHemodynamics

Outcome Measures

Primary Outcomes (3)

  • Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)

    At the end of phase at rest

    60 minutes

  • PVR AZA vs. Placebo (exercise)

    At the end of phase at exercise

    60 minutes

  • PVR AZA vs. Placebo (hypoxia)

    At the end of phase under hypoxia

    60 minutes

Secondary Outcomes (10)

  • partial pressure of the oxygen

    60 minutes

  • Oxygen uptake

    15 minutes

  • minute ventilation

    15 minutes

  • arterial oxygenation

    60 minutes

  • tissue oxygenation

    60 minutes

  • +5 more secondary outcomes

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Diamox 500mg i.v. (1x)

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

Placebo Saline injection (1x)

Drug: Placebo

Interventions

AcetazolamideDRUG
Acetazolamide
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)

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

Location

Related Publications (1)

  • 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.

    PMID: 34888330DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Silvia Ulrich, MD

    UniversityHospital Zurich

    PRINCIPAL INVESTIGATOR

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

January 1, 2017

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

CH(1)