Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

Orion Corporation, Orion Pharma32 enrolled

Overview

The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Transient Ischemic Attack Stroke

Interventions

LevosimendanDRUG

from 0.125 mg to 2 mg in escalating doses

PlaceboDRUG

Placebo capsules are identical in appearance to active capsules

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit. Exclusion Criteria: * Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection * Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period * History of life-threatening ventricular arrhythmia within 3 months. * History of Torsades de Pointes (TdP) or family history of long QT-syndrome * Heart rate (HR) \< 50 or \> 100 bpm. * Systolic blood pressure (SBP) \< 100 mmHg or \> 180 mmHg, or diastolic blood pressure (DBP) \> 100 mmHg. * Ventricular tachycardia. * Episode of atrial fibrillation or atrial flutter lasting \> 60 seconds. * Second or third degree atrioventricular (AV) block. * Potassium (K) \< 3.7 mmol/l or \> 5.5 mmol/l. * Creatinine \> 170 µmol/l or on dialysis. * Blood haemoglobin \<10 g/dl; clinically significant hepatic impairment.

Locations (7)

Helsinki University Hospital (HUCH)

Helsinki, Finland

Turku University Hospital (TYKS)

Turku, Finland

Heidelberg University Clinic

Heidelberg, Germany

Debrecen University

Debrecen, Hungary

Outcomes

Primary Outcomes

24-h Holter reporting

Time frame: every 2 weeks

Data from ClinicalTrials.gov

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