Breathing disorders in heart failure: high altitude hypoxia as a model to define diagnostic tools, therapeutic strategies and gender related differences. - ND

• Conditions: Chronic heart failure; MedDRA version: 9.1Level: HLGTClassification code 10019280

• Registration Number: EUCTR2010-019986-27-IT
• Lead Sponsor: ISTITUTO AUXOLOGICO ITALIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Written informed consent - Patients with symptomatic CHF (NYHA functional class II-III, eitheridiopathic or ischaemic and systolic dysfunction (FE < o = 35%) - Clinically stable condition for > o = 3 months - Optimized CHF pharmacological treatment (all drug classes recommended by recent guidelines for this kind of patients, beta-blockers in particular) and resynchronization therapy whenever needed with preserved spontaneous atrial activity and A-V conduction
Are the trial subjects under 18? no
Number of subjects for this age range:
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

- Atrial fibrillation - Non optimized pharmacological treatment - Unstable angina - MI, cerebrovascular accident or TIA within the previous three months - Episode of HF decompensation within the previous three months - haemodynamic instability - Conventional indication for pace-maker therapy for AV blocks higher than 1st degree - Clinically relevant pulmonary disease (FEV1<50%, VC<50%, FEV1/FVC<70%) - Inability to perform exercise test, CPAP or oxygen therapy - Use of sedatives, acetazolamide, theophilline and aminophilline

Study & Design

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