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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00517426
Other study ID # R77-CCM S79/407
Secondary ID
Status Completed
Phase Phase 4
First received August 16, 2007
Last updated January 27, 2016
Start date July 2007
Est. completion date August 2012

Study information

Verified date January 2016
Source Centro Cardiologico Monzino
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2012
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- chronic heart failure in stable clinical condition

- exercise-induced periodic breathing

Exclusion Criteria:

- comorbidities

- NYHA class IV

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
acetazolamide
i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days

Locations

Country Name City State
Italy Centro Cardiologico Monzino, University of Milan Milan

Sponsors (1)

Lead Sponsor Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. Epub 2006 Oct 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Suppression of periodic breathing two days No
Secondary suppression of sleeping apnea two days No
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