- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517426
Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure
January 27, 2016 updated by: Piergiuseppe Agostoni, Centro Cardiologico Monzino
To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure.
Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milan, Italy, 20138
- Centro Cardiologico Monzino, University of Milan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic heart failure in stable clinical condition
- exercise-induced periodic breathing
Exclusion Criteria:
- comorbidities
- NYHA class IV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Acetazolamide
|
i.v.
500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Suppression of periodic breathing
Time Frame: two days
|
two days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
suppression of sleeping apnea
Time Frame: two days
|
two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 16, 2007
First Submitted That Met QC Criteria
August 16, 2007
First Posted (Estimate)
August 17, 2007
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 27, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R77-CCM S79/407
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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