Back to resultsOpen-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Primary Purpose
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levosimendan 2.5 mg/ml Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension Pulmonary Secondary Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
- May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
- Female patients of childbearing potential must agree to use a highly effective method of contraception.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
- Pregnant or breastfeeding women.
- Local access to commercially available levosimendan
- Inability to comply with planned study procedures
- Patients with scheduled lung or heart transplant or cardiac surgery
- Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
- Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
- Weight >150kg
- Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
- Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
- Hemoglobin < 80 g/L
- Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management
Sites / Locations
- Stanford Healthcare
- Northwestern Memorial Hospital
- University of Minnesota Medical Center
- Mayo Clinic
- University of Nebraska Medical Center
- Hospital of the University of Pennsylvania
- UPMC Presbyterian Hospital
- Medical University of South Carolina
- UW Health University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levosimendan
Arm Description
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
Outcomes
Primary Outcome Measures
Clinical Safety measured by number of adverse events (AEs )
Long-term safety profile of levosimendan measured by number of adverse events (AEs )
Secondary Outcome Measures
6-minute walk test (6MWT)
Exercise capacity, measured as a distance traveled in 6 minutes
Patient global assessment
Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
Physician's Assessment of Functional Class
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
Incidence of death or hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03624010
Brief Title
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Official Title
Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tenax Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levosimendan
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Levosimendan 2.5 mg/ml Injectable Solution
Intervention Description
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 Measure Information:
Title
Clinical Safety measured by number of adverse events (AEs )
Description
Long-term safety profile of levosimendan measured by number of adverse events (AEs )
Time Frame
2 years
Secondary Outcome Measure Information:
Title
6-minute walk test (6MWT)
Description
Exercise capacity, measured as a distance traveled in 6 minutes
Time Frame
2 years
Title
Patient global assessment
Description
Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
Time Frame
2 years
Title
Physician's Assessment of Functional Class
Description
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)
Time Frame
2 years
Title
Clinical Events: Death and hospitalizations
Description
Incidence of death or hospitalization
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
Female patients of childbearing potential must agree to use a highly effective method of contraception.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
Pregnant or breastfeeding women.
Local access to commercially available levosimendan
Inability to comply with planned study procedures
Patients with scheduled lung or heart transplant or cardiac surgery
Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
Weight >150kg
Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
Hemoglobin < 80 g/L
Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Rich, MD
Organizational Affiliation
Tenax Therapeutics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Healthcare
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UW Health University Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
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