Effects of Acetazolamide and CO2 Inhalation on Exercise-i... | NCT00517426

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

NCT00517426

Sponsor

Centro Cardiologico Monzino

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Chronic Heart Failure

Interventions

acetazolamide

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jul 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 16, 2007

First Submission Date that Met QC Criteria

Aug 16, 2007

First Posted Date

Aug 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Acetazolamide	Experimental		Drug: acetazolamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acetazolamide	Drug	i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days	Active Acetazolamide

Measure	Description	Time Frame
Suppression of periodic breathing		two days

Measure	Description	Time Frame
suppression of sleeping apnea		two days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

comorbidities
NYHA class IV

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piergiuseppe Agostoni, MD, PhD	Centro Cardiologico Monzino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Cardiologico Monzino, University of Milan		Milan		20138	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17028107	Background	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. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.

ID	Term
D006333	Heart Failure
D009043	Motor Activity

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001519	Behavior

ID	Term
D013830	Thiadiazoles
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals