Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients (NCT03624010) | Clinical Trial Compass
CompletedPhase 2
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
United States35 participantsStarted 2019-04-09
Plain-language summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Safety
Timeframe: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).
. Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)