A Study of Levosimendan in Pulmonary Hypertension (PH) with Heart Failure (HF) and Preserved Left Ventricular Ejection Fraction (pEF) Patients

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-010329
    NCT ID: NCT03624010
    Sponsor Protocol Number: TNX-LVO-05

About this study

The purpose of this study is to evaluate for safety and effectiveness weekly, open-label doses of levosimendan over extended use in patients with pulmonary hypertension with heart failure and preserved left ventricular ejection fraction (PH-HFpEF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 of blinded drug 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 planning with scheduled lung or heart transplant or cardiac surgery in the next 4 months.
  • 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.
  • Evidence of systemic bacterial, systemic fungal, or viral infection in last 2 weeks refractory to treatment.
  • Weight > 150 kg.
  • 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 .

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Open for enrollment

Contact information:

Shalon Maxson R.N.

(507)255-7013

Maxson.Shalon@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available