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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Criteria to enter Open-label, Lead-in Dose Phase: - Diagnosis of WHO Group 2 Pulmonary Hypertension (PH) with heart failure and preserved ejection fraction (HFpEF) confirmed at the time of the diagnosis of pulmonary hypertension. - Baseline Pulmonary Arterial Pressure (PAP) ≥35, PCWP ≥20, NYHA Class IIb/III, Left Ventricular Ejection Fraction (LVEF) ≥40% - Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test. - Stable oxygen treatment (if applicable), and medications for heart failure, hypertension and respiratory condition Criterion for Randomization to Double-blind Phase: - Response to Open-label, Lead-in Levosimendan: Patients who demonstrate a ≥4mmHg reduction in PCWP from baseline measured at bicycle exercise (25 watts) with no more than a 10% decrease from baseline in cardiac index

Exclusion Criteria

  • Subject has primary diagnosis of PH other than Group 2 PH-HFpEF - Previous Percutaneous Coronary Intervention (PCI) or cardiac surgery (CABG) , unless they have a negative stress test in last 12 months) - Congenital heart disease - Clinically significant lung disease - Planned heart or lung surgery - Cardiac Index >4.0 L/min/m2 - Concomitant administration of pulmonary vasodilator therapy or taken within 14 days - Dialysis or Glomerular Filtration Rate (GFR) <30 mL/min/1.73 m2 - Liver dysfunction with Child Pugh Class B or C - Evidence of systemic infection - Weight > 150kg - Symptomatic systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg - Heart rate >= 100 bpm with study drug, symptomatic and persistent for at least 10 minutes - Hemoglobin < 80 g/L - Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline - Patients having severely compromised immune function - Pregnant, suspected to be pregnant, or breast-feeding

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Levosimendan 2.5mg/mL Injectable Solution 		0.075 - 0.1µg/kg/min for 24 hrs (weekly)
  • Drug: 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
    Other names:
    • Levosimendan 2.5 mg/mL Injectable Solution
Placebo Comparator
Matching Placebo 		0.075 - 0.1µg/kg/min for 24 hrs (weekly)
  • Drug: Matching Placebo
    A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
    Other names:
    • Placebo

More Details

Status
Completed
Sponsor
Tenax Therapeutics, Inc.

Study Contact

Detailed Description

Levosimendan and its prolonged active metabolite, OR-1896, have been shown to have favorable hemodynamic effects in subjects with pulmonary hypertension and right heart failure. Clinical studies that have been conducted in subjects with right heart failure and pulmonary hypertension suggest levosimendan may be an effective therapy in treatment of subjects with PH-HFpEF. This study will provide demonstration of levosimendan/OR-1896's effectiveness in critical measures of hemodynamic response in weekly administration of levosimendan and the concomitant response as measured by exercise capacity, subject quality of life, and changes in functional capacity. These data will support and guide the Phase 3 development of levosimendan in PH-HFpEF subjects.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.