At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Levosimendandrug
Likely dose
Levosimendan 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
In Brief
A Phase 2 clinical trial evaluating Levosimendan for Hypertension Pulmonary Secondary Heart Failure and 2 related conditions. Completed, enrolled 35 participants across 9 sites.
Detailed Summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
CountriesUnited States
CollaboratorsMedpace, Inc.
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartApr 2019
Primary CompletionApr 2023
TodayJul 2026
First PostedAug 9, 2018
Enrollment StartApr 9, 2019
Primary CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.9 years ago
Interventions
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)