E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with dual chamber (atrium and ventricle) cardiac pacemaker placed due to sick sinus syndrome (at least 1 month after implantation) |
Patsiendid, kellele on siinussõlme nõrkuse sündroomi tõttu varasemalt paigaldatud koja ja vatsakese elektroodiga kardiostimulaator (vähemalt 1 kuu peale implantatsiooni) |
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E.1.1.1 | Medical condition in easily understood language |
Patients who have been placed a permanent cardiac pacemaker due to heart rate problems (at least 1 month after implantation) |
Patsiendid, kellele on südame rütmihäire tõttu varasemalt paigaldatud püsikardiostimulaator (vähemalt 1 kuu pärast paigaldamist) |
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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 | 17.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10053103 |
E.1.2 | Term | Heart rate and pulse investigations |
E.1.2 | System Organ Class | 100000004848 |
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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 |
To evaluate the impact of heart rate on the effects of antihypertensive therapy on central aortic blood pressure |
Hinnata südame löögisageduse mõju hüpertensiooniravimite mõjule tsentraalsele vererõhule |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the impact of heart rate on the effects of antihypertensive therapy on pulse wave velocity, cardiac output, and peripheral vascular resistance |
Hinnata südame löögisageduse mõju hüpertensiooniravimite mõjule aordi pulsilaine kiirusele, südame minutimahule ja perifeersele vaskulaarsele resistentsusele |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-75 years
Dual chamber (atrium and ventricle) cardiac pacemaker placed due to sick sinus syndrome (at least 1 month after implantation)
Good atrioventricular conductance (PQ interval < 250 msec)
Study subject has signed the informed consent form
|
Vanus 18-75 a
Siinussõlme nõrkuse sündroomi tõttu varasemalt paigaldatud koja ja vatsakese elektroodiga kardiostimulaator (vähemalt 1 kuu peale implantatsiooni)
Hea atrioventrikulaarne ülejuhe (PQ aeg <250 ms)
Informeeritud nõusoleku vorm allkirjastatud
|
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E.4 | Principal exclusion criteria |
Patients with contraindication or intolerance to beta-blockers, ivabradine, or their adjuvants
Use of antiarrythmic drugs (sotalol, amiodarone, propafenone)
History of several episodes of atrial fibrillation
Use of antibiotics
Acute or chronic inflammatory diseases
Resting blood pressure < 110/70 mmHg
Atrioventricular conductance disorders (patient needs permanent pacing)
Long QT interval on resting ECG
Severe liver or kidney disorder
Pregnant or breast-feeding women
Women of child-bearing potential not using contraception
Previous myocardial infarction or stroke
Current stable angina pectoris
Total cardiovascular risk higher than moderate-high (in first phase)
No insurance provided by Estonian Health Insurance Fund
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• Teadaolev vastunäidustus või talumatus beetablokaatorite, ivabradiini või nende abiainete suhtes
• Antiarütmikumide kasutamine (sotalool, amiodaroon, propafenoon)
• Anamneesis korduvad kodade virvendusarütmia episoodid
• Antibakteriaalsete ravimite kasutamine
• Äge või krooniline põletikuline haigus
• Rahuoleku vererõhk < 110/70 mmHg
• Atrioventrikulaarse ülejuhte häired (patsient vajab püsivat vatsakese stimulatsiooni)
• Pikk QT-aeg rahuoleku EKG-s
• Raske maksa-või neerukahjustus
• Rasedad või rinnaga toitvad naised
• Reproduktiiveas naised, kes ei kasuta rasestumisvastaseid vahendeid
• Läbipõetud müokardiinfarkt või insult
• Käesolevalt pingutusstenokardia
• Kardiovaskulaarne lisarisk suurem kui mõõdukas-kõrge (uuringu esimeses faasis)
• Puudub Eesti Haigekassa kindlustus
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in central aortic blood pressure |
Tsentraalse vererõhu muutus |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First phase: at the day of first administration of the IMP and after 2 weeks of IMP therapy
Second phase: after 24h of changing the pacemaker`s base rate |
Esimene faas: IMP esmakordse manustamise päeval ja pärast 2-nädalast ravi IMO-ga
Teine faas: 24h pärast kardiostimulaatori baassageduse muutmist |
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E.5.2 | Secondary end point(s) |
Change in pulse wave velocity, cardiac output, and peripheral vascular resistance |
Aordi pulsilaine kiiruse, südame minutimahu ja perifeerse vaskulaarse resistentsuse muutus |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
First phase: at the day of first administration of the IMP and after 2 weeks of IMP therapy
Second phase: after 24h of changing the pacemaker`s base rate |
Esimene faas: IMP esmakordse manustamise päeval ja pärast 2-nädalast ravi IMO-ga
Teine faas: 24h pärast kardiostimulaatori baassageduse muutmist |
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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) | 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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | 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
|
The last visit of the last subject undergoing the trial. |
Viimase uuritava viimane visiit. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |