Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piergiuseppe Agostoni, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00517426
First received: August 16, 2007
Last updated: January 27, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Drug: acetazolamide
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • Suppression of periodic breathing [ Time Frame: two days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • suppression of sleeping apnea [ Time Frame: two days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: August 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Acetazolamide 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
Other Name: Diamox

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic heart failure in stable clinical condition
  • exercise-induced periodic breathing

Exclusion Criteria:

  • comorbidities
  • NYHA class IV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517426

Locations
Italy
Centro Cardiologico Monzino, University of Milan
Milan, Italy, 20138
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Piergiuseppe Agostoni, MD, PhD Centro Cardiologico Monzino
  More Information

Publications:
Responsible Party: Piergiuseppe Agostoni, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00517426     History of Changes
Other Study ID Numbers: R77-CCM S79/407 
Study First Received: August 16, 2007
Last Updated: January 27, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
heart failure,
exercise
periodic breathing,
acetazolamide

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2016