Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
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ClinicalTrials.gov Identifier: NCT03624010 |
Recruitment Status :
Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : April 30, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Pulmonary Secondary Heart Failure Right Sided Heart Failure With Normal Ejection Fraction Heart Failure With Normal Ejection Fraction | Drug: Levosimendan 2.5 mg/ml Injectable Solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Open-label |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF) |
Actual Study Start Date : | November 14, 2018 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | February 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Levosimendan
A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
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Drug: Levosimendan 2.5 mg/ml Injectable Solution
A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion |
- Clinical Safety measured by number of adverse events (AEs ) [ Time Frame: 2 years ]Long-term safety profile of levosimendan measured by number of adverse events (AEs )
- 6-minute walk test (6MWT) [ Time Frame: 2 years ]Exercise capacity, measured as a distance traveled in 6 minutes
- Patient global assessment [ Time Frame: 2 years ]Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
- Physician's Assessment of Functional Class [ Time Frame: 2 years ]Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity)
- Clinical Events: Death and hospitalizations [ Time Frame: 2 years ]Incidence of death or hospitalization

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
- May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
- Female patients of childbearing potential must agree to use a highly effective method of contraception.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
- Pregnant or breastfeeding women.
- Local access to commercially available levosimendan
- Inability to comply with planned study procedures
- Patients with scheduled lung or heart transplant or cardiac surgery
- Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
- Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
- Weight >150kg
- Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
- Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
- Hemoglobin < 80 g/L
- Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624010
United States, California | |
Stanford Healthcare | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Minnesota | |
University of Minnesota Medical Center | |
Minneapolis, Minnesota, United States, 55455 | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
UPMC Presbyterian Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Wisconsin | |
UW Health University Hospital | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Stuart Rich, MD | Tenax Therapeutics, Inc. |
Responsible Party: | Tenax Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03624010 |
Other Study ID Numbers: |
TNX-LVO-05 |
First Posted: | August 9, 2018 Key Record Dates |
Last Update Posted: | April 30, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension, Pulmonary Hypertension Heart Failure Dextrocardia Vascular Diseases Cardiovascular Diseases Heart Diseases Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Situs Inversus |
Lung Diseases Respiratory Tract Diseases Simendan Cardiotonic Agents Vasodilator Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |