E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
heart failure |
scompenso cardiaco |
|
E.1.1.1 | Medical condition in easily understood language |
heart failure |
scompenso cardiaco |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007636 |
E.1.2 | Term | Cardiomyopathy |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063083 |
E.1.2 | Term | Chronic left ventricular failure |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007561 |
E.1.2 | Term | Cardiac failure left |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
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 |
Exercise time at 6 minute walking test Maximal oxygen consumption during exercise |
Capacità di esercizio, consumo di ossigeno massimale |
|
E.2.2 | Secondary objectives of the trial |
Quality of life Improvement in quality of life muscle strength Achievement of maximal therapeutic doses |
qualità di vita miglioramento classe NYA forza muscolare raggiungimento dosaggio terapeutico ottimale |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Heart failure (chronic) 18 years or older not on beta-blockers or if on beta-blockers not receiving adequate ACE-inhibitor dose Exercise capacity >100<600 m |
scompenso cardiaco età >18 anni non in terapia con beta-bloccanti o se in terapia con beta-bloccanti in terapia sub-ottimale con ACE-inibitori capacità di eserczio tra 100 e 600 metri |
|
E.4 | Principal exclusion criteria |
recent hospitalisation scheduled hospitalization bradicardia pace-maker with pacing rate > 50 bpm ventricular arrhythmia (Lown class 3 or greater) |
- Pace maker, defibrillatore impiantabile
- donne in età fertile che non abbiano in atto mezzi di controllo delle nascite, donne in gravidanza ed allattamento
- Limitazioni funzionali o ortopediche che impediscano l’esecuzione dei test di funzionalità cardiovascolare
- ipersensibilità accertata e/o controindicazioni all’impiego dei farmaci dello studio
- pz in trattamento con farmaci che possono prolungare il QT (es. amiodarone, bepridil, sotalolo, ibutilide, mefloquine, halofantrine, pentamidine, cisapride, sparfloxacine, pimozide, ziprasidone, sertindole, aloperidolo, antidepressivi imipraminici) o con diltiazem verapamil, antiaritmici classe I (chinidina, procainamide, lidocaina, flecainide, propafenone, fenitoina), forti inibitori del citocromo P450 3A4 (CYP3A4) (antibiotici macrolidi (come claritromicina,eritromicina,telitromicina,josamicina…), ciclosporina, farmaci antiretrovirali (come ritonavir, nelfinavir, saquinavir, delavirdine), agenti antifungini somministrati per via sistemica ( come ketoconazolo, itraconazolo,…),
- intervallo QTc >450msec,
- intolleranza al lattosio
- pz in attesa di interventi chirurgici o con neoplasie o in terapia antitumorale/immunosoppressiva,
- soggetti che non abbiano firmato il consenso informato, pz incapace di proseguire nello studio, pz. inclusi in altri studi clinici o che abbiano terminato un altro protocollo clinico da meno di un mese. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Exercise time at 6 minute walking test Maximal oxygen consumption during cardiopulmonary exercise test |
Capacità di esercizio al test dei 6 minuti consumo di ossigeno massimale al test cardiopolmonare |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Quality of life Improvement in quality of life muscle strength Achievement of maximal therapeutic doses |
qualità di vita miglioramento classe NYA forza muscolare raggiungimento dosaggio terapeutico ottimale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |