Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF

• Status: Completed
• Trial end date: 2020-04-07
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tenax Therapeutics, Inc.
• Treatments: Pharmaceutical Solutions; Simendan

Criteria

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