NCT00517426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

August 16, 2007

Last Update Submit

January 27, 2016

Conditions

Chronic Heart Failure

Keywords

heart failure,exerciseperiodic breathing,acetazolamide

Outcome Measures

Primary Outcomes (1)

  • Suppression of periodic breathing

    two days

Secondary Outcomes (1)

  • suppression of sleeping apnea

    two days

Study Arms (1)

Active Acetazolamide

EXPERIMENTAL
Drug: acetazolamide

Interventions

acetazolamideDRUG

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

Also known as: Diamox
Active Acetazolamide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • comorbidities
  • NYHA class IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino, University of Milan

Milan, 20138, Italy

Location

Related 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. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.

    PMID: 17028107BACKGROUND

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Piergiuseppe Agostoni, MD, PhD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2011

Study Completion

August 1, 2012

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

IT(1)