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An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

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This is an open-label rollover study to continue treatment Levosimendan of subjects who were participated in the Tenax sponsored study after they have completed the 04 parent study.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
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

Drug: Levosimendan 2.5 mg/ml Injectable Solution

Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction

Gretchen Peichel - gpeichel@umn.edu
Thenappan Thenappan
Phase 2
STUDY00006731
NCT03624010
See this study on ClinicalTrials.gov

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