MedTrace Logo

Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients

NCT03624010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-22

Study results available
· View outcomes & findings →

Summary

PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.

Conditions

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

Interventions

DRUG

Levosimendan

Initial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID)

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Tenax Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Rich, MD · Tenax Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2023-04-25
Completion
2023-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624010 on ClinicalTrials.gov