Chronic heart failure MedDRA version: 9.1 Level: HLGT Classification code 10019280
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetazolamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Patients with symptomatic CHF (NYHA functional class II-III, eitheridiopathic or ischaemic and systolic dysfunction (FE 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of multicenter study is to analyze the prevalence and the pathogenetic mechanisms of periodic breathing during sleep in healthy subjects exposed to hypobaric hypoxia conditions.;Secondary Objective: - Screening a relatively large group of subjects with chronic heart failure (CHF), to estimate the prevalence, severity and features of sleep-related and exercise-related breathing disorders. - To explore the relationship of such breathing disorders to subject`s gender, haemodynamic, cardiac autonomic, neurohormonal characteristics, both in healthy subjects at altitude and in CHF patients. - Development and testing of a new textile-based wearable system (MagIC, Maglietta Interattiva Computerizzata), aimed at acquiring unobtrusive recordings of cardiorespiratory and motion signals during spontaneous sleeping behaviour.;Primary end point(s): 1) to analyze the prevalence and the pathogenetic mechanisms of periodic breathing during sleep in healthy subjects at high altitude, and at sea level in heart failure patients; only in CHF patients, to explore the mechanisms related to developing periodic breathing during exercise. 2) to evaluate the gender related differences in developing periodic breathing during sleep and exercise in the same two populations and conditions. 3) To finalize the development and testing of a new textile-based wearable system (MagIC, Maglietta Interattiva Computerizzata), aimed at acquiring unobtrusive recordings of cardiorespiratory and motion signals during spontaneous sleeping behaviour. | — |
Countries
Italy
Outcome results
None listed