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NCT03624010 · ClinicalTrials.gov registry record · Phase 2
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
A Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure, sponsored by Tenax Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 9
- Study locations
NCT03624010: Completed Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure, sponsored by Tenax Therapeutics.
NCT03624010 is a Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure that has completed, run by Tenax Therapeutics. The registered enrollment target is 20 participants, below the 638-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03624010, a Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure, has completed, sponsored by Tenax Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 9
- Study locations
Study Summary
PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Primary Outcome
Number of Adverse Events per Patient Population
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 |
What the finished NCT03624010 record still lists
NCT03624010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 638-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (97% lower).
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.
NCT03624010 lists 9 locations in 7 states (Minnesota, Pennsylvania, California).
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.
What interventions are being tested in trial NCT03624010?
The interventions under investigation include: Levosimendan 2.5 mg/ml Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT03624010?
This trial is sponsored by Tenax Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03624010's enrollment target sits among peer trials
20 9th of 10 higher than 2 of 10 other Heart Failure With Normal Ejection Fraction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Normal Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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