Trial · NCT01168908

Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy

NCT01168908, Phase 2, Terminated, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.; results first posted 2018-03-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. Trials, record NCT01168908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168908

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Trial

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

Title: Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
NCT number: NCT01168908
Status: Terminated
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions: Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Interventions: Sildenafil
First posted: 2010-07-23
Last updated: 2019-02-26
Results first posted: 2018-03-21

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.	6 months compared to baseline	To determine whether a 6 month trial of oral sildenafil compared to placebo improves cardiac contractile function in DBMD as determined by a \> 10% decline in end-systolic volume as detected by CMR.
Secondary	Change in Cardiac Systolic and Diastolic Function by CMR	6 months and 12 months	Cardiac volumes and systolic ejection parameters will be measured.
Secondary	Change in Cardiac Mass	6 months and 12 months	Left ventricular (LV) mass will be measured by CMR .
Secondary	Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing	6 months and 12 months	Skeletal muscle function of the diaphragm will be measured using FVC by pulmonary function testing.
Secondary	Change in Skeletal Muscle Strength	6 months and 12 months	Skeletal muscle strength will be assessed by pincher and grip dynamometry
Secondary	Ejection Fraction	6 months	Left ventricular ejection fraction by cardiac MRI was measured

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.	6 months compared to baseline	ml	MEAN
SECONDARY	Change in Cardiac Systolic and Diastolic Function by CMR	6 months and 12 months	ml	MEAN
SECONDARY	Change in Cardiac Mass	6 months and 12 months	grams	MEAN
SECONDARY	Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing	6 months and 12 months	liters	MEAN
SECONDARY	Change in Skeletal Muscle Strength	6 months and 12 months	pounds	MEAN
SECONDARY	Ejection Fraction	6 months	percentage of volume	MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.	Revatio (Sildenafil)		5.2	Standard Deviation 23.61	ml
Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.	Placebo		-0.19	Standard Deviation 5.56	ml
Change in Cardiac Systolic and Diastolic Function by CMR	Revatio (Sildenafil)	LV end-diastolic volume	5.54	Standard Deviation 18.85	ml
Change in Cardiac Systolic and Diastolic Function by CMR	Placebo	LV end-diastolic volume	0.24	Standard Deviation 8.78	ml
Change in Cardiac Systolic and Diastolic Function by CMR	Revatio (Sildenafil)	stroke volume	0.34	Standard Deviation 9.75	ml
Change in Cardiac Systolic and Diastolic Function by CMR	Placebo	stroke volume	0.43	Standard Deviation 11.46	ml
Change in Cardiac Mass	Revatio (Sildenafil)		-3.4	Standard Deviation 7.03	grams
Change in Cardiac Mass	Placebo		-1.05	Standard Deviation 12.69	grams
Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing	Revatio (Sildenafil)		-0.13	Standard Deviation 0.09	liters
Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing	Placebo		-0.19	Standard Deviation 0.21	liters

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Double Blind, Placebo Controlled	STARTED	Revatio (Sildenafil)	10
Double Blind, Placebo Controlled	STARTED	Placebo	10
Double Blind, Placebo Controlled	COMPLETED	Revatio (Sildenafil)	7
Double Blind, Placebo Controlled	COMPLETED	Placebo	8
Double Blind, Placebo Controlled	NOT COMPLETED	Revatio (Sildenafil)	3
Double Blind, Placebo Controlled	NOT COMPLETED	Placebo	2
Open Label	STARTED	Revatio (Sildenafil)	7
Open Label	STARTED	Placebo	8
Open Label	COMPLETED	Revatio (Sildenafil)	6
Open Label	COMPLETED	Placebo	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

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	Dizziness	General disorders	Revatio (Sildenafil)	1	18	1
other	Dizziness	General disorders	Placebo	0	10	0
other	gastroparesis	Gastrointestinal disorders	Revatio (Sildenafil)	1	18	1
other	gastroparesis	Gastrointestinal disorders	Placebo	0	10	0
other	Headache	Nervous system disorders	Revatio (Sildenafil)	1	18	1
other	Headache	Nervous system disorders	Placebo	2	10	2
other	tachycardia	Cardiac disorders	Revatio (Sildenafil)	1	18	1
other	tachycardia	Cardiac disorders	Placebo	0	10	0
other	low blood pressure	Cardiac disorders	Revatio (Sildenafil)	4	18	4
other	low blood pressure	Cardiac disorders	Placebo	0	10	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Revatio (Sildenafil)	1	18
Total, all-cause mortality	Placebo	0	10
Total, other adverse events	Revatio (Sildenafil)	13	18
Total, other adverse events	Placebo	7	10
Total, serious adverse events	Revatio (Sildenafil)	5	18
Total, serious adverse events	Placebo	1	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25042693	DERIVED

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 comparisons2

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

Comparison	Source
Revatio (Sildenafil) vs Placebo: deaths from any cause	Trial comparisons
Revatio (Sildenafil) 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.

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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/NCT01168908

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