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Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables (Electro)

Primary Purpose

Transient Ischemic Attack, Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Levosimendan
Placebo
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Ischemic Attack focused on measuring An ischaemic cerebrovascular event (stroke or TIA)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Helsinki University Hospital (HUCH)
  • Turku University Hospital (TYKS)
  • Heidelberg University Clinic
  • Debrecen University
  • Sahlgrenska University Hospital, Dept of Neurology
  • University Hospital, Neurologmottagningen
  • Umeå University Hospital, Strokecenter NVS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Levosimendan

Placebo

Outcomes

Primary Outcome Measures

24-h Holter reporting

Secondary Outcome Measures

Full Information

First Posted
June 12, 2008
Last Updated
November 23, 2009
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00698763
Brief Title
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
Acronym
Electro
Official Title
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Stroke
Keywords
An ischaemic cerebrovascular event (stroke or TIA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Levosimendan
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Description
from 0.125 mg to 2 mg in escalating doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules are identical in appearance to active capsules
Primary Outcome Measure Information:
Title
24-h Holter reporting
Time Frame
every 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irja Korpela
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Risto O. Roine, M.D., Ph.D.
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital (HUCH)
City
Helsinki
Country
Finland
Facility Name
Turku University Hospital (TYKS)
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Heidelberg University Clinic
City
Heidelberg
Country
Germany
Facility Name
Debrecen University
City
Debrecen
Country
Hungary
Facility Name
Sahlgrenska University Hospital, Dept of Neurology
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
University Hospital, Neurologmottagningen
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Umeå University Hospital, Strokecenter NVS
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26082815
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.
Results Reference
derived

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Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

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