Trial · NCT03541603

Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF

NCT03541603, Phase 2, Completed, Tenax Therapeutics, Inc.; results first posted 2024-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF. Trials, record NCT03541603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03541603

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
NCT number: NCT03541603
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: Tenax Therapeutics, Inc.
Conditions: Hypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
Interventions: Levosimendan, Matching Placebo
First posted: 2018-05-30
Last updated: 2024-11-20
Results first posted: 2024-05-14
Limitations and caveats: Hemodynamic effects at Wk6 were measured \~1 week after final levosimendan infusion. Thus, hemodynamic effects at 6 weeks represent effects at trough levels; greater effects might have been observed with earlier assessment.~No previous study evaluated chronic levosimendan in PH-HFpEF. Chose a low dose out of an abundance of caution. It remains possible that higher doses may be more effective in selected patients.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise	Baseline, Week 6	Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
Secondary	Change in Cardiac Index (CI) at Rest and With Exercise.	Baseline, Week 6	Change in Cardiac Index (CI) at rest and with exercise at Week 6 (CI determined by thermodilution) (CI is a hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA))
Secondary	Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Baseline, Week 6	Change in Pulmonary Vascular Resistance (PVR) effect at rest and with exercise at Week 6
Secondary	Change in PCWP When Supine and Legs Elevated	Baseline, Week 6	Change in Pulmonary Capillary Wedge Pressure, Baseline to Week 6
Secondary	Patient Global Assessment	Baseline, Week 6	Patient assessment of well-being based on 6 questions assessed on a 5-point Likert Scale ( 1 =worst, 5= best) (minimum total score 5pts, maximum total score 25 pts) (no comparison to baseline as no instrument used at baseline)
Secondary	Exercise Duration Via 6 Minute Walk Test	Baseline, Week 6	Change in 6-minute walk test at Week 6 vs baseline
Secondary	Physician's Assessment of Functional Class	Baseline, Week 6	Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity).
Secondary	Number of Participants With Composite Events of Death or Hospitalization	Baseline, Week 6	Number of Participants with Composite Events of death or hospitalization through Week 6

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise	Baseline, Week 6	patients completing Baseline and Week 6 visit with hemodynamic data	mmHg	MEAN
SECONDARY	Change in Cardiac Index (CI) at Rest and With Exercise.	Baseline, Week 6	patients completing Baseline and Week 6 visit with hemodynamic data	L/min/m^2	MEAN
SECONDARY	Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Baseline, Week 6	patients completing Baseline and Week 6 visit with hemodynamic data	mmHg.min/L	MEAN
SECONDARY	Change in PCWP When Supine and Legs Elevated	Baseline, Week 6	patients completing Baseline and Week 6 visit with hemodynamic data	mmHg	MEAN
SECONDARY	Patient Global Assessment	Baseline, Week 6		units on a scale	MEDIAN
SECONDARY	Exercise Duration Via 6 Minute Walk Test	Baseline, Week 6		meters	MEAN
SECONDARY	Physician's Assessment of Functional Class	Baseline, Week 6		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Composite Events of Death or Hospitalization	Baseline, Week 6		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise	Levosimendan 2.5mg/mL Injectable Solution		-1.9	Standard Deviation 10.07	mmHg
Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise	Matching Placebo		-0.5	Standard Deviation 7.87	mmHg
Change in Cardiac Index (CI) at Rest and With Exercise.	Levosimendan 2.5mg/mL Injectable Solution	rest	0.05	Standard Deviation 0.699	L/min/m^2
Change in Cardiac Index (CI) at Rest and With Exercise.	Matching Placebo	rest	-0.15	Standard Deviation 0.262	L/min/m^2
Change in Cardiac Index (CI) at Rest and With Exercise.	Levosimendan 2.5mg/mL Injectable Solution	exercise	0.24	Standard Deviation 1.106	L/min/m^2
Change in Cardiac Index (CI) at Rest and With Exercise.	Matching Placebo	exercise	0.04	Standard Deviation 0.594	L/min/m^2
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Levosimendan 2.5mg/mL Injectable Solution	rest	-0.09	Standard Deviation 1.050	mmHg.min/L
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Matching Placebo	rest	0.15	Standard Deviation 2.238	mmHg.min/L
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Levosimendan 2.5mg/mL Injectable Solution	exercise	-0.44	Standard Deviation 1.539	mmHg.min/L
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise	Matching Placebo	exercise	-0.16	Standard Deviation 1.81	mmHg.min/L

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Levosimendan 2.5mg/mL Injectable Solution	18
Overall Study	STARTED	Matching Placebo	19
Overall Study	COMPLETED	Levosimendan 2.5mg/mL Injectable Solution	18
Overall Study	COMPLETED	Matching Placebo	17
Overall Study	NOT COMPLETED	Levosimendan 2.5mg/mL Injectable Solution	0
Overall Study	NOT COMPLETED	Matching Placebo	2

Source ClinicalTrials.gov

Adverse events122

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Levosimendan 2.5mg/mL Injectable Solution	1	18	1
other	Fatigue	General disorders	Matching Placebo	2	19	2
other	Chills	General disorders	Levosimendan 2.5mg/mL Injectable Solution	1	18	1
other	Chills	General disorders	Matching Placebo	1	19	1
other	Infusion site hemorrhage	General disorders	Levosimendan 2.5mg/mL Injectable Solution	1	18	1
other	Infusion site hemorrhage	General disorders	Matching Placebo	1	19	1
other	Infusion site erythema	General disorders	Levosimendan 2.5mg/mL Injectable Solution	1	18	1
other	Infusion site erythema	General disorders	Matching Placebo	0	19	0
other	Edema	General disorders	Levosimendan 2.5mg/mL Injectable Solution	1	18	1
other	Edema	General disorders	Matching Placebo	0	19	0

1 to 10 of 122Source ClinicalTrials.gov

See all 122 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Levosimendan 2.5mg/mL Injectable Solution	0	18
Total, all-cause mortality	Matching Placebo	0	19
Total, other adverse events	Levosimendan 2.5mg/mL Injectable Solution	13	18
Total, other adverse events	Matching Placebo	8	19
Total, serious adverse events	Levosimendan 2.5mg/mL Injectable Solution	3	18
Total, serious adverse events	Matching Placebo	1	19

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33839076	DERIVED	PubMed
34716759	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Levosimendan 2.5mg/mL Injectable Solution vs Matching Placebo: Number of Participants With Composite Events of Death or Hospitalization	Trial comparisons
Levosimendan 2.5mg/mL Injectable Solution vs Matching Placebo: deaths from any cause	Trial comparisons
Levosimendan 2.5mg/mL Injectable Solution vs Matching Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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