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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624010
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Tenax Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 24, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE November 14, 2018
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
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 )
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Clinical Safety measured by number of adverse events (AEs ) [ Time Frame: 72 weeks ]
Long-term safety profile of levosimendan measured by number of adverse events (AEs )
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • 6-minute walk test (6MWT) [ Time Frame: 2 years ]
    Exercise capacity, measured as a distance traveled in 6 minutes
  • Patient global assessment [ Time Frame: 2 years ]
    Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
  • 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)
  • Clinical Events: Death and hospitalizations [ Time Frame: 2 years ]
    Incidence of death or hospitalization
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • 6-minute walk test (6MWT) [ Time Frame: 72 weeks ]
    Exercise capacity, measured as a distance traveled in 6 minutes
  • Patient global assessment [ Time Frame: 72 weeks ]
    Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
  • Physician's Assessment of Functional Class [ Time Frame: 72 weeks ]
    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)
  • Change in Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: 48 weeks ]
    Change in measurements from baseline in the parent clinical study sponsored by Tenax Therapeutics, Inc.
  • Change in Cardiac Index (CI) [ Time Frame: 48 weeks ]
    Change in measurements from baseline in the parent clinical study sponsored by Tenax Therapeutics, Inc.
  • Change in Pulmonary Pulmonary Vascular Resistance (PVR) [ Time Frame: 48 weeks ]
    Change in measurements from baseline in the parent clinical study sponsored by Tenax Therapeutics, Inc.
  • Change in echo measurements of right ventricle (RV) size [ Time Frame: 48 weeks ]
    Change in measurements from baseline in the parent clinical study sponsored by Tenax Therapeutics, Inc.
  • Change in echo measurements of tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 48 weeks ]
    Change in measurements from baseline in the parent clinical study sponsored by Tenax Therapeutics, Inc.
  • Clinical Events: Death and hospitalizations [ Time Frame: 72 weeks ]
    Incidence of death or hospitalization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Official Title  ICMJE Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Brief Summary PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension Pulmonary Secondary Heart Failure
  • Right Sided Heart Failure With Normal Ejection Fraction
  • Heart Failure With Normal Ejection Fraction
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: Levosimendan 2.5 mg/ml Injectable Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624010
Other Study ID Numbers  ICMJE TNX-LVO-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tenax Therapeutics, Inc.
Study Sponsor  ICMJE Tenax Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tenax Therapeutics, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP