Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF

Completed · Phase 2 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT03541603

Run by

Tenax Therapeutics, Inc.

People needed

44

Starts

2018-11-14

Expected to finish

2020-04-07

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Criteria to enter Open-label, Lead-in Dose Phase:
• Diagnosis of World Health Organization (WHO) Group 2 Pulmonary Hypertension (PH) with Heart Failure with Preserved Ejection Fraction (HFpEF) confirmed at the time of the diagnosis of pulmonary hypertension.
• Baseline Pulmonary Arterial Pressure (PAP) ≥35, Pulmonary Capillary Wedge Pressure (PCWP) ≥20, New York Heart Association (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

You may not qualify if…

• Subject has a 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 the 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 the 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

Where it is running

• Stanford Healthcare — Stanford, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• North Shore University Hospital — Manhasset, New York, United States
• New York Presbyterian Hospital-Weill Cornell Medicine — New York, New York, United States
• Ichan School of Medicine at Mount Sinai — New York, New York, United States
• Christ Hospital — Cincinnati, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UW Health University Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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