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Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
NCT03624010 · View on ClinicalTrials.gov ↗
Study Summary
PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Conditions Studied
Interventions
- DRUG Levosimendan 2.5 mg/ml Injectable Solution
Study Locations (9)
Minnesota
- University of Minnesota Medical Center — Minneapolis
- Mayo Clinic — Rochester
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
- UPMC Presbyterian Hospital — Pittsburgh
California
- Stanford Healthcare — Stanford
Illinois
- Northwestern Memorial Hospital — Chicago
Nebraska
- University of Nebraska Medical Center — Omaha
South Carolina
- Medical University of South Carolina — Charleston
Wisconsin
- UW Health University Hospital — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03624010
The ClinicalTrials.gov registry entry for NCT03624010 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tenax Therapeutics, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Heart Failure With Normal Ejection Fraction appearing as the primary indexed condition, and to 1 intervention — of which Levosimendan 2.5 mg/ml Injectable Solution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03624010 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Minnesota, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03624010 about?
NCT03624010 is a clinical study titled "Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients". PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
What is the current status of trial NCT03624010?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-11-14. Estimated completion is 2024-02-01.
What conditions does trial NCT03624010 study?
This clinical trial studies the following conditions: Heart Failure With Normal Ejection Fraction, Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03624010?
The interventions under investigation include: Levosimendan 2.5 mg/ml Injectable Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03624010?
This trial is sponsored by Tenax Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03624010 being conducted?
This trial has 9 study locations across California, Illinois, Minnesota, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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