Hypertension Pulmonary Secondary Heart FailurePhase 2NCT03624010
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
A Phase 2 study testing Levosimendan in people with Hypertension Pulmonary Secondary Heart Failure and Right Sided Heart Failure With Normal Ejection Fraction, run by Tenax Therapeutics, Inc. at 9 sites in United States.
Trial summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- What is being tested?
- Levosimendan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 Apr 2019to 25 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
UW Health University Hospital
Madison, Wisconsin, 53792
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Stanford Healthcare
Stanford, California, 94305
About this study
Official title: 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 open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Read the detailed description
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
- Conditions
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Being tested
- Levosimendan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Initial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID)
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan Open-Label | Other | Initial: 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. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Safety
Number of Adverse Events per Patient Population
Measured: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start9 Apr 2019
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension Pulmonary Secondary Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Stuart Rich, MD, Principal investigator, Tenax Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624010
- Sponsor's protocol ID
- TNX-LVO-05
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2018
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
- ClinicalTrials.gov ID
- NCT03624010
- Acronym / sponsor ID
- TNX-LVO-05
- Conditions
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Detailed description
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Levosimendan Open-Label | Other | Drug: LevosimendanInitial: 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. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevosimendanInitial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID) | Drug | Levosimendan Open-Label |
Primary outcome
Clinical Safety
Time frame: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).
Number of Adverse Events per Patient Population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypertension Pulmonary Secondary Heart Failure
Active, not recruitingPhase 2
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Rich, MD principal investigator
Tenax Therapeutics, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levosimendan in people with Hypertension Pulmonary Secondary Heart Failure and Right Sided Heart Failure With Normal Ejection Fraction, run by Tenax Therapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Safety (time frame: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.