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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000746-20-DE

Enrollment

150

Registered

2006-05-15

Start date

2006-10-09

Completion date

Unknown

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with diastolic dysfunction

Interventions

Product Name: Nebivolol Pharmaceutical Form: Tablet INN or Proposed INN: Nebivolol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the pla

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 (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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Germany, Portugal

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026