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Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude

Primary Purpose

Altitude Hypoxia

Status
Active
Phase
Phase 4
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
ACETAZOLAMIDE oral capsule
Placebo oral capsule
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Altitude Hypoxia focused on measuring healthy participants older than 40 years, right heart function during exercise, prevention, acetazolamide

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men and women, age 40-75 yrs, without any disease and need of medication.
  • Born, raised and currently living at low altitude (<800m).
  • Written informed consent.
  • Kyrgyz ethnicity

Exclusion Criteria:

  • Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
  • Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol.
  • Allergy to acetazolamide and other sulfonamides.

Sites / Locations

  • National Center of Cardiology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ACETAZOLAMIDE oral capsule

PLACEBO oral capsule

Arm Description

Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Outcomes

Primary Outcome Measures

pulmonary artery pressure (PAP) during exercise
Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer

Secondary Outcome Measures

pulmonary artery pressure during exercise
Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
cardiac Output (CO) during exercise
Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
cardiac output during exercise
Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
PAP/CO slope during exercise
Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
PAP/CO slope during exercise
Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Oxygen saturation
Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter
Oxygen saturation
Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter

Full Information

First Posted
May 15, 2018
Last Updated
November 1, 2022
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
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1. Study Identification

Unique Protocol Identification Number
NCT03537924
Brief Title
Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude
Official Title
Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.
Detailed Description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis on right heart function during exercise in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m. An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altitude Hypoxia
Keywords
healthy participants older than 40 years, right heart function during exercise, prevention, acetazolamide

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACETAZOLAMIDE oral capsule
Arm Type
Active Comparator
Arm Description
Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
Arm Title
PLACEBO oral capsule
Arm Type
Placebo Comparator
Arm Description
Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
Intervention Type
Drug
Intervention Name(s)
ACETAZOLAMIDE oral capsule
Intervention Description
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Primary Outcome Measure Information:
Title
pulmonary artery pressure (PAP) during exercise
Description
Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 3100m
Secondary Outcome Measure Information:
Title
pulmonary artery pressure during exercise
Description
Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 760 m and 3100 m
Title
cardiac Output (CO) during exercise
Description
Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 3100m
Title
cardiac output during exercise
Description
Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 760 m and 3100 m
Title
PAP/CO slope during exercise
Description
Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 3100m
Title
PAP/CO slope during exercise
Description
Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Time Frame
Day 2 at 760 m and 3100 m
Title
Oxygen saturation
Description
Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter
Time Frame
Day 2 at 3100m
Title
Oxygen saturation
Description
Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter
Time Frame
Day 2 at 760 m and 3100 m

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women, age 40-75 yrs, without any disease and need of medication. Born, raised and currently living at low altitude (<800m). Written informed consent. Kyrgyz ethnicity Exclusion Criteria: Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol. Allergy to acetazolamide and other sulfonamides.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev,, MD
Organizational Affiliation
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Furian, M
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan

12. IPD Sharing Statement

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Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude

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