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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:November 14, 2018
End Date:December 2021
Contact:Kevin Crawford
Email:k.crawford@tenaxthera.com
Phone:919-855-2145

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Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

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

This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study.
These patients will receive weekly open-label doses of levosimendan and be periodically
evaluated for safety and effectiveness in extended use.

Inclusion Criteria:

1. Provide a personally signed and dated informed consent document prior to initiation of
any study-related procedures that are not considered standard of care.

2. Received levosimendan as treatment for PH-HFpEF in a clinical study sponsored by Tenax
Therapeutics, Inc.

3. May, in the opinion of the Investigator, benefit from continued levosimendan
treatment.

4. Male patients and female patients of childbearing potential must agree to use a highly
effective method of contraception.

5. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests and other study procedures.

Exclusion Criteria:

1. Discontinued treatment in the parent study for any reason other than study completion
or Sponsor termination of the study.

2. Pregnant or breastfeeding women.

3. Local access to commercially available levosimendan
We found this trial at
6
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Rochester, Minnesota 55905
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Rochester, MN
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Stanford, California 94305
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Stanford, CA
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