Clinical trial NCT00698763: Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Official title: Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transient Ischemic Attack
Stroke
Keywords: An ischaemic cerebrovascular event (stroke or TIA)
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-h Holter reporting
timeFrame: every 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital (HUCH)
city: Turku
country: Finland
facility: Turku University Hospital (TYKS)
city: Heidelberg
country: Germany
facility: Heidelberg University Clinic
city: Debrecen
country: Hungary
facility: Debrecen University
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Neurology
city: Linköping
country: Sweden
facility: University Hospital, Neurologmottagningen
city: Umeå
country: Sweden
facility: Umeå University Hospital, Strokecenter NVS
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Irja Korpela
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Risto O. Roine, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kivikko M, Kuoppamaki M, Soinne L, Sundberg S, Pohjanjousi P, Ellmen J, Roine RO. Oral Levosimendan Increases Cerebral Blood Flow Velocities in Patients with a History of Stroke or Transient Ischemic Attack: A Pilot Safety Study. Curr Ther Res Clin Exp. 2015 Jan 29;77:46-51. doi: 10.1016/j.curtheres.2015.01.001. eCollection 2015 Dec.