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Effect of Acetazolamide on Right Heart Function at Rest 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, 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

Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group
Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo groups

Secondary Outcome Measures

Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
cardiac output
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
cardiac output
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
right heart dimensions
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
right heart dimensions
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
right heart function
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
right heart function
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
stroke volume
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
stroke volume
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
volumes
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
volumes
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography

Full Information

First Posted
May 15, 2018
Last Updated
March 9, 2023
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
NCT03540914
Brief Title
Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.
Official Title
Effect of Acetazolamide on Right Heart Function at Rest 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
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (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 at rest 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 preventive acetazolamide intake on right heart function at rest 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, prevention, acetazolamide

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (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
Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group
Description
Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo groups
Time Frame
Day 2 at 760m and 3100m
Secondary Outcome Measure Information:
Title
Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
Description
Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
Time Frame
Day 2 at 3100m
Title
cardiac output
Description
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3100m
Title
cardiac output
Description
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
Time Frame
Day 2 at 3100m
Title
right heart dimensions
Description
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3100m
Title
right heart dimensions
Description
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 3100m
Title
right heart function
Description
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time Frame
Day 2 at 760m and 3100m
Title
right heart function
Description
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time Frame
Day 2 at 3100m
Title
stroke volume
Description
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3100m
Title
stroke volume
Description
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
Time Frame
Day 2 at 3100m
Title
volumes
Description
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3100m
Title
volumes
Description
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 3100m

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, MSc
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

Learn more about this trial

Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.

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