Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)

NCT ID: NCT00563693

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-01-31

Brief Summary

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An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.

Detailed Description

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Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.

Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.

Conditions

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Heart Failure Cheyne Stokes Respiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

The patients use ASV

Group Type EXPERIMENTAL

ASV

Intervention Type DEVICE

Adaptive servo ventilator

without Autoset CS2

Intervention Type OTHER

without Autoset CS2

B

Patients without ASV

Group Type ACTIVE_COMPARATOR

without Autoset CS2

Intervention Type OTHER

without Autoset CS2

Interventions

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ASV

Adaptive servo ventilator

Intervention Type DEVICE

without Autoset CS2

without Autoset CS2

Intervention Type OTHER

Other Intervention Names

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AutoSet CS2

Eligibility Criteria

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Inclusion Criteria

* Ejection fraction \<40%
* NYHA class III-IV
* Optimized therapy with drugs
* Cheyne stokes respiration pattern \> 25% while sleeping
* Age \< 85 years
* clinical stability the last month before inclusion.

Exclusion Criteria

* CABG less then 6 months ago
* PCI treatment less then 3 months ago
* Unstable angina pectoris
* Acute coronary syndrome less then 3 months ago
* Stroke less then 6 weeks ago
* Thoracal myopathy
* Advanced COPD
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Arild Hetland

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arild Hetland, cardiologist

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Sykehuset ostfold Fredrikstad

Fredrikstad, , Norway

Site Status

Countries

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Norway

Other Identifiers

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1.2007.980

Identifier Type: -

Identifier Source: org_study_id