At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Levosimendan +1 moredrug
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.
A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
In Brief
A Phase 2 clinical trial evaluating Levosimendan and Matching Placebo for Hypertension Pulmonary Secondary and 2 related conditions. Completed, enrolled 44 participants across 16 sites.
Detailed Summary
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartNov 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedMay 30, 2018
Enrollment StartNov 14, 2018
Primary CompletionApr 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.1 years ago
Interventions
Levosimendandrug
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
Matching Placebodrug
A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion