LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

UCI Specialty Area: Pulmonology

Principal Investigator: Bassam Yaghmour

Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

A Study On:

Lung - Pulmonary

Study Description

This study will evaluate the efficacy of TNX-103 (levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

This is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12. Subjects will return to the clinical site at Weeks 4, 8, and 12.

All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

Eligibility

Men or women, greater than or equal to18 to 85 years of age.
NYHA Class II or III or ambulatory NYHA class IV symptoms.
A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
A qualifying Baseline RHC performed within 120 days. The RHC can be a historical RHC done prior to study consent.
A qualifying echocardiogram performed within 30 days showing an LVEF greater than or equal to 40%
A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening
A 48-hour ambulatory cardiac rhythm monitor during the Screening Period to establish the resting heart rate (HR) and rhythm.
Chronic medications for heart failure with preserved ejection fraction (HFpEF) or other serious underlying cardiac or pulmonary conditions should be administered at a stable dose for greater than or equal to 30 days prior to the day of the Baseline 6-MWT.
Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening Visit and a negative urine pregnancy test and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 7 months after the last dose of study drug.
Female subjects of childbearing potential will be included if they are either sexually inactive (abstinent) for 90 days prior to the first dose of study drug, or are using a highly effective birth control method
Female subjects of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile or postmenopausal.
Male patients with female partners of childbearing potential must use highly effective methods of birth control during their participation in the study and for a period of 4 months after the last dose of study drug.
Patients must agree to abstain from egg or sperm donation through 7 months for female patients and 4 months for male patients after administration of the last dose of study drug.
Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
Signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study.

NOTE: Other protocol-defined Inclusion/

Exclusion Criteria apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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