Trial · NCT01971580

The Effects of Ambrisentan on Exercise Capacity in Fontan Patients

NCT01971580, Phase 4, Completed, Washington University School of Medicine; results first posted 2018-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effects of Ambrisentan on Exercise Capacity in Fontan Patients. Trials, record NCT01971580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01971580

On this page

Trial

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

Title: The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
NCT number: NCT01971580
Status: Completed
Phases: Phase 4
Enrollment: 28 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Single Ventricle Fontan Palliation
Interventions: Ambrisentan
First posted: 2013-10-29
Last updated: 2018-05-07
Results first posted: 2018-05-07
Limitations and caveats: Large dropout rate. Small sample size. Many individuals did not achieve the target RER during cardiopulmonary exercise testing.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change in VO2 Max	Baseline compared to 12 weeks therapy with either ambrisentan or placebo
Secondary	Quality of Life	12 weeks	Change in Rand 36-item Short Form (SF-36) physical function score (0-100). On the Rand SF-36 questionnaire, a score closer to 100 (higher) suggests lesser disability, while a score closer to 0 (lower) suggests more disability.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in VO2 Max	Baseline compared to 12 weeks therapy with either ambrisentan or placebo	In this crossover study, all patients received both ambrisentan and placebo. Data was analyzed comparing baseline measures to those after the period on ambrisentan and baseline measures to those after the period on placebo.	Change in ml/kg min	MEAN
SECONDARY	Quality of Life	12 weeks	In this crossover study, all patients received both therapies. Analysis was performed comparing baseline to after indicated therapy	Change in score from baseline	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change in VO2 Max	On Ambrisentan Therapy	1.33	95% Confidence Interval -0.92 to 3.57	Change in ml/kg min
Change in VO2 Max	On Placebo	0.745	95% Confidence Interval -2.06 to 2.42	Change in ml/kg min
Quality of Life	On Ambrisentan Therapy	3.75	95% Confidence Interval -5.78 to 13.2	Change in score from baseline
Quality of Life	On Placebo	0.195	95% Confidence Interval -9.34 to 9.73	Change in score from baseline

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ambrisentan First, Placebo Second	14
Overall Study	STARTED	Placebo First, Ambrisentan Second	14
Overall Study	COMPLETED	Ambrisentan First, Placebo Second	10
Overall Study	COMPLETED	Placebo First, Ambrisentan Second	9
Overall Study	NOT COMPLETED	Ambrisentan First, Placebo Second	4
Overall Study	NOT COMPLETED	Placebo First, Ambrisentan Second	5

Source ClinicalTrials.gov

Adverse events22

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	Rhinitis or Pharyngitis	Respiratory, thoracic and mediastinal disorders	On Ambrisentan Therapy	6	19	6
other	Rhinitis or Pharyngitis	Respiratory, thoracic and mediastinal disorders	On Placebo	8	19	8
other	edema	Skin and subcutaneous tissue disorders	On Ambrisentan Therapy	3	19	3
other	edema	Skin and subcutaneous tissue disorders	On Placebo	2	19	2
other	rash	Skin and subcutaneous tissue disorders	On Ambrisentan Therapy	2	19	2
other	rash	Skin and subcutaneous tissue disorders	On Placebo	3	19	3
other	arthralgia	Musculoskeletal and connective tissue disorders	On Ambrisentan Therapy	0	19	0
other	arthralgia	Musculoskeletal and connective tissue disorders	On Placebo	1	19	1
other	cough/dyspnea	Respiratory, thoracic and mediastinal disorders	On Ambrisentan Therapy	4	19	4
other	cough/dyspnea	Respiratory, thoracic and mediastinal disorders	On Placebo	3	19	3

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	On Ambrisentan Therapy	0	19
Total, all-cause mortality	On Placebo	0	19
Total, other adverse events	On Ambrisentan Therapy	13	19
Total, other adverse events	On Placebo	14	19
Total, serious adverse events	On Ambrisentan Therapy	1	19
Total, serious adverse events	On Placebo	0	19

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
On Ambrisentan Therapy vs On Placebo: deaths from any cause	Trial comparisons
On Ambrisentan Therapy vs On 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/NCT01971580

GET https://conductscience.org/api/trials/v1/NCT01971580/events?page=2

API reference For AI assistants