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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019464-37-IT
Enrollment
Unknown
Registered
2012-03-30
Start date
2011-04-14
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients hospitalized for heart failure and central sleep apnea syndrome in the Cardiovascular Medicine Department, Fondazione G. Monasterio, Pisa MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: NA Product Code: NA Pharmaceutical Form: Inhalation gas INN or Proposed INN: Carbon dioxide Concentration unit: % percent Concentration number: 20- Product Name: NA Product Code: NA Pha

Sponsors

FONDAZIONE TOSCANA GABRIELE MONASTERIO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary end point(s): Number of apnoea/hypopnoea per hour (AHI: apnea hypopnoea index) at cardiorespiratory monitoring;Main Objective: To evaluate the clinical effects of carbon dioxide administration using a dynamic flow (cosine shape) in heart failure patients with central sleep apnea syndrome. This is a phase 2 trial evaluating the treatment efficacy.;Secondary Objective: Neurohormonal status and, in particular, adrenergic drive assessment Arrhythmias at electrocardiographic monitoring Sleep architecture Sleep quality and daytime fatigue Cardiac haemodynamics—

Countries

Italy

Contacts

Public ContactMedicina cardiovascolare

FONDAZIONE TOSCANA GABRIELE MONASTERIO ENTE OSPEDALIERO E DI RICERCA CNR/REGIONE TOSCANA-OSPEDALE G.PASQUINUCCI MASSA PR

passino@ftgm.it050-3153229

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026