Trial · NCT03037580

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction

NCT03037580, Phase 3, Terminated, United Therapeutics; results first posted 2020-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction. Trials, record NCT03037580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03037580

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Trial

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

Title: Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
NCT number: NCT03037580
Status: Terminated
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Interventions: Oral treprostinil, Placebo
First posted: 2017-01-31
Last updated: 2020-11-10
Results first posted: 2020-10-22

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change in 6MWD From Baseline to Week 24	Baseline to Week 24	The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Secondary	Change in NT-proBNP Levels From Baseline to Week 24	Baseline to Week 24	The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.
Secondary	Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Baseline to Week 24	Clinical worsening was defined as the occurrence of any 1 of the following clinical worsening events: hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to PH and/or heart failure), outpatient administration of IV diuretics, death (all causes), decrease in 6MWD \>15% from Baseline (or the subject was too ill to walk, and the cause was directly related to the disease under study) at 2 consecutive visits on different days (except Week 24).
Secondary	Change in WHO FC From Baseline to Week 24	Baseline to Week 24	The WHO functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in 6MWD From Baseline to Week 24	Baseline to Week 24	Safety Population	meters	MEDIAN
SECONDARY	Change in NT-proBNP Levels From Baseline to Week 24	Baseline to Week 24	Safety Population	pmol/L	MEDIAN
SECONDARY	Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Baseline to Week 24	Safety Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in WHO FC From Baseline to Week 24	Baseline to Week 24	Safety Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Change in 6MWD From Baseline to Week 24	Oral Treprostinil		21.0	Full Range -195 to 62	meters
Change in 6MWD From Baseline to Week 24	Placebo		23.3	Full Range -140 to 104	meters
Change in NT-proBNP Levels From Baseline to Week 24	Oral Treprostinil		9.5	Full Range -133 to 499	pmol/L
Change in NT-proBNP Levels From Baseline to Week 24	Placebo		11.5	Full Range -231 to 172	pmol/L
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Oral Treprostinil	First Clinical Worsening Event	6		Participants
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Placebo	First Clinical Worsening Event	5		Participants
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Oral Treprostinil	No clinical worsening event	35		Participants
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24	Placebo	No clinical worsening event	38		Participants
Change in WHO FC From Baseline to Week 24	Oral Treprostinil	Baseline / WHO FC I	1		Participants
Change in WHO FC From Baseline to Week 24	Placebo	Baseline / WHO FC I	1		Participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Treprostinil	41
Overall Study	STARTED	Placebo	43
Overall Study	COMPLETED	Oral Treprostinil	25
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Oral Treprostinil	16
Overall Study	NOT COMPLETED	Placebo	16

Source ClinicalTrials.gov

Adverse events110

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	Diarrhoea	Gastrointestinal disorders	Oral Treprostinil	19	41	23
other	Diarrhoea	Gastrointestinal disorders	Placebo	16	43	19
other	Headache	Nervous system disorders	Oral Treprostinil	22	41	27
other	Headache	Nervous system disorders	Placebo	12	43	14
other	Nausea	Gastrointestinal disorders	Oral Treprostinil	13	41	14
other	Nausea	Gastrointestinal disorders	Placebo	6	43	7
other	Fatigue	General disorders	Oral Treprostinil	8	41	10
other	Fatigue	General disorders	Placebo	10	43	13
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Oral Treprostinil	7	41	7
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Placebo	9	43	10

1 to 10 of 110Source ClinicalTrials.gov

See all 110 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Treprostinil	0	41
Total, all-cause mortality	Placebo	1	43
Total, other adverse events	Oral Treprostinil	37	41
Total, other adverse events	Placebo	38	43
Total, serious adverse events	Oral Treprostinil	11	41
Total, serious adverse events	Placebo	8	43

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Oral Treprostinil vs Placebo: deaths from any cause	Trial comparisons
Oral Treprostinil vs 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.

GET https://conductscience.org/api/trials/v1/NCT03037580

GET https://conductscience.org/api/trials/v1/NCT03037580/results?page=2

API reference For AI assistants