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Trial record 2 of 9 for:    tenax

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624010
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Tenax Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertension Pulmonary Secondary Heart Failure Right Sided Heart Failure With Normal Ejection Fraction Heart Failure With Normal Ejection Fraction Drug: Levosimendan 2.5 mg/ml Injectable Solution Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levosimendan
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 infusion
Drug: Levosimendan 2.5 mg/ml Injectable Solution
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 infusion




Primary Outcome Measures :
  1. Clinical Safety measured by number of adverse events (AEs ) [ Time Frame: 2 years ]
    Long-term safety profile of levosimendan measured by number of adverse events (AEs )


Secondary Outcome Measures :
  1. 6-minute walk test (6MWT) [ Time Frame: 2 years ]
    Exercise capacity, measured as a distance traveled in 6 minutes

  2. Patient global assessment [ Time Frame: 2 years ]
    Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)

  3. Physician's Assessment of Functional Class [ Time Frame: 2 years ]
    Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity)

  4. Clinical Events: Death and hospitalizations [ Time Frame: 2 years ]
    Incidence of death or hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
  3. May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
  4. 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
  4. Inability to comply with planned study procedures
  5. Patients with scheduled lung or heart transplant or cardiac surgery
  6. Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
  7. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
  8. Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
  9. Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
  10. Weight >150kg
  11. Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
  12. Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
  13. Hemoglobin < 80 g/L
  14. Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624010


Contacts
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Contact: Kevin Crawford 919-855-2145 k.crawford@tenaxthera.com
Contact: Douglas Hay 919-855-2110 d.hay@tenaxthera.com

Locations
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United States, California
Stanford Healthcare Recruiting
Stanford, California, United States, 94305
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
New York Presbyterian Hospital-Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Ohio
Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Wisconsin
UW Health University Hospital Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Tenax Therapeutics, Inc.

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Responsible Party: Tenax Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03624010     History of Changes
Other Study ID Numbers: TNX-LVO-05
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Heart Failure
Dextrocardia
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Situs Inversus
Lung Diseases
Respiratory Tract Diseases
Simendan
Pharmaceutical Solutions
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs