E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancers treated with anthracyclines: leukemias, limphomas, breast, stomach, uterine, ovarian, lung. |
Vėžiniai susirgimai gydomi antraciklinų grupės preparatais: leukemijos, limfomos, krūties, skrandžio, gimdos, kiaušidžių, plaučių. |
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E.1.1.1 | Medical condition in easily understood language |
Cancer: blood, lymphnode, breast, stomach, uterine, ovarian, lung. |
Vėžys: kraujo, limfmazgių, krūties, skrandžio, gimdos, kiaušidžių, plaučių. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.
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Tyrimo tikslas yra įvertinti kardioprotekcines ivabradino savybes antraciklinais gydomiems pacientams.
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E.2.2 | Secondary objectives of the trial |
1. Incidence of anthracyclines induced cardiotoxicity and heart failure. 2. Incidence of major cardiovascular outcomes. |
1. Kardiotoksinės antraciklinių chemoterapijos sukelto širdies pažeidimo ir širdies nepakankamumo išsivystymo dažnis. 2. Didžiųjų nepageidaujamų kardiovaskulinių reiškinių dažnis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Chemotherapy with anthracyclines; • Age 18-80 years; • Heart rate ≥ 70 times per minute; • Written informed consent. |
• Pacientai, gydomi antraciklinais; • Amžius 18-80 m.; • Pulsas ≥ 70 k./min.; • Pacientai turi norėti ir sugebėti užpildyti informuoto asmens sutikimo formą (lengvai bendrauti su tyrėju ir neturėti psichikos sutrikimų). |
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E.4 | Principal exclusion criteria |
• Contraindications for ivabradine administration; • heart rate <70 times per minute; • Incapability to complete informed consent; • Severe valve disease; • Left ventricle ejection fraction ≤ 30 proc.; • Poor echogenicity.
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• Kontraindikacijos ivabradino skyrimui. • Pulsas < 70 k./min.; • Nesugebėjimas užpildyti informuoto asmens sutikimo formos; • Vožtuvų stenozė arba nesandarumas, didesnis nei vidutinio laipsnio; • Kairiojo skilvelio išstūmio frakcija ≤ 30 proc.; • Nepakankamai gera analizei širdies echoskopijos vaizdų kokybė.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction of ≥ 3%. 2. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP. 3. Incidence of left ventricular systolic and diastolic dysfunction.
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1. Įvertinti miokardo bendrosios išilginės deformacijos kitimo dinamiką gydymo antraciklinais metu. 2. Įvertinti miokardo pažaidą (vertinant didelio jautrumo troponino I (TnI) koncentracijos bei plazmos smegenų tipo natriuretinio propeptido (NT-proBNP) koncentracijos kitimus) gydymo antraciklainais metu. 3. Įvertinti kardiotoksinę chemoterapiją bei ivabradiną gaunančių pacientų kairiojo skilvelio sistolinės bei diastolinės funkcijų pokyčius gydymo antraciklainais metu.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines. |
Po 1, 3, 6 ir 7 mėnesių nuo antraciklinių chemoterapijos pradžios. |
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E.5.2 | Secondary end point(s) |
1. Incidence of symptomatic heart failure. 2. Incidence of adverse effects of ivabradine. 3. Change in left ventricle and right ventricle dimensions by 2D and 3D echocardiography. 4. Subgroup analysis by gender, age, type of cancer, cardiovascular risk factors.
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1. Simptominio širdies nepakankamumo išsivystymo dažnis. 2. Kairiojo ir dešiniojo skilvelio dydžio kitimų dinamika 2D ir 3D echokardioskopijos metu. 3. Subgrupių analizė pagal lytį, amžių, vėžio tipą ir kardiovaskulinius rizikos veiksnius.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial. |
Tyrimo pabaigoje. |
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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 | Yes |
E.6.3 | Therapy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
įprastinis gydymas |
Usual care |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | 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
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LVLS |
Paskutinio paciento paskutinis vizitas. |
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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 |