effects of dynamic co2 therapy in periodic breathing in heart failure patients - CO2

• Conditions: Patients hospitalized for heart failure and central sleep apnea syndrome in the Cardiovascular Medicine Department, Fondazione G. Monasterio, Pisa; MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-019464-37-IT
• Lead Sponsor: FONDAZIONE TOSCANA GABRIELE MONASTERIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-30
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Systolic heart failure (echocardiographic evidence of left ventricular ejection fraction lower than 50%)
Central sleep apnea syndrome with an AHI >15
4 days of hospitalization
Ability to spontaneously express informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Haemodynamic instability following myocardial infarction, unstable angina, cardiac surgery or major arrhythmias in the 3 months preceding the study
Neurologic disorders or use of neurotropic drugs with potential effects on the respiratory drive
Major psychiatric disorders including alcohol abuse or drug addiction
Creatine clearance < 20 ml/min;
Pregnancy
Administration of every experimental drug within the 30 days before recruitment in the current study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified