E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with diastolic dysfunction |
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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 |
This study is designed to assess the long-term effects of the administration of nebivolol, compared to placebo, on the clinical symptoms, exercise capacity and parameters of left ventricular function in the patients with diastolic heart failure. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1)The subject is aged ≥40 years 2a) Symptoms of heart failure; a documented history of heart failure 3a) A left ventricular ejection fraction ≥ 45% assessed by echocardiography, radionuclide ventriculography or magnetic resonance (MRI) 4a) NYHA functional class II or III 6a) The subject has given written informed consent for participation in the study. The subject is able and willing to visit the hospital for the planned study visits 10) Any diastolic abnormality well documented on echocardiography following the diagnostic criteria for diastolic heart failure published by the 'European Study Group on Diastolic Heart Failure'
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E.4 | Principal exclusion criteria |
1. The subject is unable to perform a 6 minutes walking test 3. Planned invasive cardiac procedures carried out during the study e.g. 6 months after randomization 4. The subject had recently (< 3 months) unstable angina, acute myocardial infarction or stroke treated with a beta blocker 5. The subject has exercise induced myocardial ischemia as a main cause of exercise impairment as shown by limiting symptoms (angina) or by the previous exams (exercise test, exercise echocardiography or myocardial scintigraphy) 6. The subject has concomitant diseases (COPD, peripheral arterial disease, orthopedic diseases) as the main cause of exercise impairment 7. Presence of major contraindications to beta-blocker therapy: severe sinus bradycardia (<50 beats/min), atrio-ventricular block, bronchial asthma sensitive to beta-agonist agents 8. The subject is treated with verapamil or diltiazem 9. The subject has a systolic blood pressure < 100 mmHg 10a. The subject is pregnant, or breast feading, or of childbearing potential without using adequate contraception. 11. The subject has a history of alcohol or other illicit drug abuse 12a. The subject suffers from any other medical condition that may interfere with the objective of the study according to the investigator's judgment. 13a. The subject is expected to have a poor compliance to drug therapy. 14a. The subject is participating in any other clinical trial with an investigational product, or the subject is scheduled to recieve any such product during the study or in the 4 weeks following the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The distance as recorded in the 6 minutes walking test |
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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 | 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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |