E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10019280 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
- 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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |