Clinical trials: Levosimendan
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Hypertension Pulmonary Secondary, Heart Failure, Right Sided
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
- Conditions
- Hypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
- Trial name
- HELP (NCT03541603)
- Testing
- Levosimendan
- Where
- 16 sites in United States
- Volunteers
- 44 people
- Sponsor
- Tenax Therapeutics, Inc.
Pulmonary Hypertension
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
- Trial name
- LEVEL (NCT05983250)
- Testing
- TNX-103
- Where
- 42 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- Tenax Therapeutics, Inc.
Amyotrophic Lateral Sclerosis
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan.
- Trial name
- REFALS-ES (NCT03948178)
- Testing
- Levosimendan
- Where
- 79 sites in United States, Australia and 12 more
- Volunteers
- 227 people
- Sponsor
- Orion Corporation, Orion Pharma
Heart Decompensation
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
- Trial name
- NCT02973620
- Testing
- Levosimendan
- Sponsor
- Tenax Therapeutics, Inc.
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
- Conditions
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Trial name
- NCT03624010
- Testing
- Levosimendan
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Tenax Therapeutics, Inc.
Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
Efficacy and Clinical Outcomes of Levosimendan in E-CPR
Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation.
- Trial name
- ECPR (NCT05730907)
- Testing
- Levosimendan
- Where
- Qatar
- Volunteers
- 100 people
- Sponsor
- Hamad Medical Corporation
Pulmonary Hypertension Associated With HFpEF
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular…
- Trial name
- LEVEL-2 (NCT07288398)
- Testing
- TNX-103
- Where
- 140 sites in United States, Argentina and 13 more
- Volunteers
- 540 people
- Sponsor
- Tenax Therapeutics, Inc.
Coronary Heart Disease
Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass
The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.
- Trial name
- NCT00130871
- Testing
- levosimendan
- Where
- 2 sites in Finland
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Heart Failure
Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.
The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure.
- Trial name
- NCT00219388
- Testing
- Levosimendan
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Heart Failure, Congestive
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.
- Trial name
- NCT00048425
- Testing
- Levosimendan
- Where
- 166 sites in United States, Australia and 2 more
- Volunteers
- 600 people
- Sponsor
- Abbott
Pulmonary Hypertension Associated With HFpEF
Long-Term Open-Label Extension Study of Oral Levosimendan
The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with…
- Trial name
- NCT07436689
- Testing
- TNX-103
- Where
- 10 sites in United States
- Volunteers
- 800 people
- Sponsor
- Tenax Therapeutics, Inc.
Acute Heart Failure
Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.
- Trial name
- NCT00348504
- Testing
- levosimendan, dobutamine
- Where
- United States
- Volunteers
- 1,300 people
- Sponsor
- Abbott
Transient Ischemic Attack, Stroke
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables
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).
- Trial name
- Electro (NCT00698763)
- Testing
- Levosimendan
- Where
- 7 sites in Finland, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Orion Corporation, Orion Pharma
Amyotrophic Lateral Sclerosis
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale.
- Trial name
- REFALS (NCT03505021)
- Testing
- Levosimendan
- Where
- 104 sites in United States, Australia and 12 more
- Volunteers
- 496 people
- Sponsor
- Orion Corporation, Orion Pharma
Chronic Heart Failure, Heart Diseases
Peroral Levosimendan in Chronic Heart Failure
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality.
- Trial name
- NCT00130884
- Testing
- levosimendan
- Where
- Finland
- Volunteers
- 300 people
- Sponsor
- Orion Corporation, Orion Pharma