NCT00455611

Brief Summary

To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

March 8, 2013

Status Verified

April 1, 2007

Enrollment Period

6.6 years

First QC Date

April 2, 2007

Last Update Submit

March 7, 2013

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, CongestiveContinuous Positive Airway PressureBaroreflexEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration

Interventions

CPAP (Continuous Positive Airway Pressure)DEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of heart failure
  • Chronic heart failure
  • Ejection fraction \< 40%

You may not qualify if:

  • Age \< 18 years
  • Permanent atrial fibrillation
  • Infiltrative cardiomyopathy
  • Mild/moderate chronic obstructive lung disease
  • Chronic heart failure
  • Diabetes mellitus
  • Chronic kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza

Turin, Piedmont, 10154, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Federico Olliveri, MD

    ospedale San Giovanni Bosco ASL4

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

May 1, 2006

Primary Completion

December 1, 2012

Last Updated

March 8, 2013

Record last verified: 2007-04

Locations

IT(1)