Trial · NCT02617446

The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure

NCT02617446, Phase 2, Completed, Windtree Therapeutics; results first posted 2023-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure. Trials, record NCT02617446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02617446

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Trial

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

Title: The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure
NCT number: NCT02617446
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Windtree Therapeutics
Conditions: Acute Decompensated Heart Failure
Interventions: Placebo, Istaroxime
First posted: 2015-12-01
Last updated: 2023-05-24
Other registries' IDs: eudract:2013-000540-26
Results first posted: 2023-05-24
Limitations and caveats: The major limitation of this study regards enrollment discrepancies between the study populations and sites of the two cohorts, with Cohort 2 enrolling exclusively Asian patients. We observed that patients enrolled in this trial were younger and with a better renal function compared to other studies.

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	Change in E/Ea Ratio	24 hours	Change from baseline at 24 hours in the unitless ratio of E (cm/sec) to Ea (or e') (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/Ea ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows Ea velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal.
Secondary	Change in LVEF	24 hours	Change from baseline at 24 hours in LV ejection fraction (LVEF) by tissue Doppler
Secondary	Change in SVI	24 hours	Change from baseline at 24 hours in stroke volume index (SVI) by tissue Doppler
Secondary	Change in E/A Ratio	24 hours	Change from baseline at 24 hours in E/A ratio by tissue Doppler
Secondary	Change in LV End Systolic Volume	24 hours	Change from baseline in left ventricular end systolic volume (LVESV) by tissue Doppler
Secondary	Change in LV End Diastolic Volume	24 hours	Change from baseline in left ventricular end diastolic volume (LVEDV) by tissue Doppler
Secondary	Change in Dyspnea	24 hours	Measured using a visual analog scale (0 to 100). Higher scores indicate less dyspnea.
Other	Change in cTnT	24 hours	Safety endpoint: Changes in troponin (cTnT)
Other	Change in eGFR	24 Hours	Safety endpoint: Change from baseline in estimated glomerular filtration rate (eGFR)
Other	Participants With Clinically or Hemodynamically Significant Episodes of Arrhythmias	24 hours	Safety endpoint: Number of participants with incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in E/Ea Ratio	24 hours	Intent-to-Treat	Unitless ratio	LEAST_SQUARES_MEAN
SECONDARY	Change in LVEF	24 hours	Intent-to-Treat	% of blood leaving the heart	MEAN
SECONDARY	Change in SVI	24 hours	Intent-to-Treat	mL/m²	LEAST_SQUARES_MEAN
SECONDARY	Change in E/A Ratio	24 hours	Intent-to-Treat	Unitless ratio	LEAST_SQUARES_MEAN
SECONDARY	Change in LV End Systolic Volume	24 hours	Intent-to-Treat	mL	LEAST_SQUARES_MEAN
SECONDARY	Change in LV End Diastolic Volume	24 hours	Intent-to-Treat	mL	LEAST_SQUARES_MEAN
SECONDARY	Change in Dyspnea	24 hours	Intent-to-Treat	Score on a scale (Visual Analog Scale)	MEAN
OTHER_PRE_SPECIFIED	Change in cTnT	24 hours	Intent-to-Treat	ng/L	MEAN
OTHER_PRE_SPECIFIED	Change in eGFR	24 Hours	Safety Population	ml/min/1.73·m²	MEAN
OTHER_PRE_SPECIFIED	Participants With Clinically or Hemodynamically Significant Episodes of Arrhythmias	24 hours	Safety Population	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group228

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

Outcome	Group	Value	Spread	Units
Change in E/Ea Ratio	Istaroxime 0.5 µg/kg/Min	-4.55	95% Confidence Interval -6.05 to -3.04	Unitless ratio
Change in E/Ea Ratio	Placebo Cohort I	-1.55	95% Confidence Interval -3.77 to 0.67	Unitless ratio
Change in E/Ea Ratio	Istaroxime 1.0 µg/kg/Min	-3.16	95% Confidence Interval -4.09 to -2.24	Unitless ratio
Change in E/Ea Ratio	Placebo Cohort II	-1.08	95% Confidence Interval -2.30 to 0.13	Unitless ratio
Change in LVEF	Istaroxime 0.5 µg/kg/Min	3.026	95% Confidence Interval 1.850 to 4.203	% of blood leaving the heart
Change in LVEF	Placebo Cohort I	1.263	95% Confidence Interval -0.401 to 2.927	% of blood leaving the heart
Change in LVEF	Istaroxime 1.0 µg/kg/Min	3.818	95% Confidence Interval 2.362 to 5.275	% of blood leaving the heart
Change in LVEF	Placebo Cohort II	2.833	95% Confidence Interval 0.861 to 4.805	% of blood leaving the heart
Change in SVI	Istaroxime 0.5 µg/kg/Min	5.334	95% Confidence Interval 3.371 to 7.296	mL/m²
Change in SVI	Placebo Cohort I	1.649	95% Confidence Interval -1.126 to 4.425	mL/m²

1 to 10 of 228Source ClinicalTrials.gov

See all 228 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	39
Overall Study	STARTED	Istaroxime 0.5 µg/kg/Min	41
Overall Study	STARTED	Istaroxime 1.0 µg/kg/Min	40
Overall Study	COMPLETED	Placebo	35
Overall Study	COMPLETED	Istaroxime 0.5 µg/kg/Min	39
Overall Study	COMPLETED	Istaroxime 1.0 µg/kg/Min	33
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Istaroxime 0.5 µg/kg/Min	2
Overall Study	NOT COMPLETED	Istaroxime 1.0 µg/kg/Min	7

Source ClinicalTrials.gov

Adverse events132

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	Arrythmia	Cardiac disorders	Placebo	0	39	0
other	Arrythmia	Cardiac disorders	Istaroxime 0.5 µg/kg/Min	0	41	0
other	Arrythmia	Cardiac disorders	Istaroxime 1.0 µg/kg/Min	2	40	2
other	Atrial fibrillation	Cardiac disorders	Placebo	0	39	0
other	Atrial fibrillation	Cardiac disorders	Istaroxime 0.5 µg/kg/Min	4	41	4
other	Atrial fibrillation	Cardiac disorders	Istaroxime 1.0 µg/kg/Min	0	40	0
other	Cardiac failure	Cardiac disorders	Placebo	3	39	3
other	Cardiac failure	Cardiac disorders	Istaroxime 0.5 µg/kg/Min	0	41	0
other	Cardiac failure	Cardiac disorders	Istaroxime 1.0 µg/kg/Min	0	40	0
other	Palpitations	Cardiac disorders	Placebo	1	39	1

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	39
Total, all-cause mortality	Istaroxime 0.5 µg/kg/Min	0	41
Total, all-cause mortality	Istaroxime 1.0 µg/kg/Min	2	40
Total, other adverse events	Placebo	23	39
Total, other adverse events	Istaroxime 0.5 µg/kg/Min	31	41
Total, other adverse events	Istaroxime 1.0 µg/kg/Min	33	40
Total, serious adverse events	Placebo	2	39
Total, serious adverse events	Istaroxime 0.5 µg/kg/Min	2	41
Total, serious adverse events	Istaroxime 1.0 µg/kg/Min	6	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31975496	RESULT

Source 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 comparisons0

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

None in this release.

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.

GET https://conductscience.org/api/trials/v1/NCT02617446

GET https://conductscience.org/api/trials/v1/NCT02617446/registered?page=2

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