Effects Of The Long-Term Administration Of Nebivolol On The Clinical Symptoms, Exercise Capacity And Left Ventricular Function Of The Patients With Diastolic Dysfunction (ELANDD) - ELANDD

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

- Subjects is aged =40 years
- Symptoms of heart failure; a documented history of heart failure
- A left ventricular ejection fraction = 45% assessed by echocardiography, radionuclide ventriculography or magnetic resonance (MRI)
- NYHA functional class II or III
- 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
- 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'

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The subject is unable to perform a 6 minutes walking test
- Planned invasive cardiac procedures carried out during the study e.g. 6 months after randomisation
- The subject had recently (< 3 months) unstable angina, acute myocardial infarction or stroke treated with a beta-blocker
- 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)
- The subject has concomitant diseases (COPD (FEV1 < 50%), peripheral arterial disease, orthopedic diseases) as the main cause of exercise impairment
- Presence of major contraindications to beta-blocker therapy, such as severe sinus bradycardia (<50 beats/min), atrio-ventricular block, bronchial asthma sensitive to beta-agonist agents, unstable heart failure, sick sinus syndrome including sino-atrial block, untreated pheochromocytoma, metabolic acidosis, hypotension and severe peripheral vascular disturbances.
- The subject is treated with verapamil or diltiazem
- The subject has a systolic blood pressure < 100 mmHg
- The subject is pregnant, or breast feeding, or of childbearing potential without using adequate contraception. Adequate methods of contraception are: hormonal contraception-oral, patch or progestagens injection-, vaginal ring, Intra-uterine device, all methods, which demonstrate a failure rate <1 %).
- The subject has a history of alcohol or other illicit drug abuse
- The subject suffers from any other medical condition that may exclude the patient for safety reasons or interfere with the objective of the study according to the investigator’s judgment
- The subject is expected to have a poor compliance to the study drug therapy
- The subject is participating in any other clinical trial with an investigational product, or the subject is scheduled to receive any such product during the study or in the 4 weeks following the study
- A left ventricular ejection fraction < 45% assessed by any one of the methods use during the study e.g. echocardiography, radionuclide ventriculography or magnetic resonance imaging (MRI)
- Uncontrolled arterial hypertension defined as >160/95 mmHg.
- Systolic cardiac insufficiency for which the treatment with beta blockers is indicated.
- Any significant alteration of the hepatic function defined as a 2 fold increase of transaminases.
- Hypersensitivity to NebiletÒ or its excipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: ;Primary end point(s): The distance as recorded in the 6 minutes walking test

Secondary Outcome Measures

Name	Time	Method

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