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Completed

NCT Number: NCT00563693

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Cheyne Stokes Respiration Cheyne-Stokes Respiration Heart Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset ostfold Fredrikstad

Fredrikstad, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASV

Device

Adaptive servo ventilator

Other names: AutoSet CS2

without Autoset CS2

Other

without Autoset CS2

Primary outcomes

  1. Ejection fraction (measured with echocardiography) and inflammatory markers

    Time frame: 3 months

Secondary outcomes

  1. 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • ResMed

Registry information

Official study title

Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).

Acronym: 3C

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 26, 2007
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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