Trial · NCT00429364

Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome

NCT00429364, Phase 3, Completed, Carelon Research; results first posted 2015-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome. Trials, record NCT00429364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429364

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Trial

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

Title: Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome
NCT number: NCT00429364
Status: Completed
Phases: Phase 3
Enrollment: 608 participants, actual
Lead sponsor: Carelon Research
Conditions: Marfan Syndrome
Interventions: Losartan Potassium, Atenolol
First posted: 2007-01-31
Last updated: 2025-03-07
Results first posted: 2015-04-01
Limitations and caveats: The effect of losartan on TGF-β was not assessed. The study results do not apply to Marfan subjects whose BSA-adj. aortic-root z score is ≤3.~Subjects may find their treatment based on the appearance of the drug.

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score	Up to 3 years following randomization.	The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization
Secondary	Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension	Up to 3 years following randomization.	The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization
Secondary	Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.	Up to 3 years following randomization.
Secondary	Annual Rate of Change in the Absolute Diameter of the Ascending Aorta	Up to 3 years following randomization.
Secondary	Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area	Up to 3 years following randomization.
Secondary	Annual Rate of Change in the Absolute Diameter of the Aortic Annulus	Up to 3 years following randomization.
Secondary	Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area	Up to 3 years following randomization.
Secondary	Annual Rate of Change in Weight	Up to 3 years following randomization.
Secondary	Annual Rate of Change in Weight-for-age Z-score	Up to 3 years following randomization.
Secondary	Annual Rate of Change in Weight-for-height Z-score	Up to 3 years following randomization.

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	Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score	Up to 3 years following randomization.		z-score/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension	Up to 3 years following randomization.		cm/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.	Up to 3 years following randomization.	All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.	z-score/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in the Absolute Diameter of the Ascending Aorta	Up to 3 years following randomization.	All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.	cm/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area	Up to 3 years following randomization.	All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.	z-score/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in the Absolute Diameter of the Aortic Annulus	Up to 3 years following randomization.	All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.	cm/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area	Up to 3 years following randomization.	All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.	(mm^2/m^2)/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Weight	Up to 3 years following randomization.		kg/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Weight-for-age Z-score	Up to 3 years following randomization.	All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.	z-score/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Rate of Change in Weight-for-height Z-score	Up to 3 years following randomization.	All randomized participants who were \<120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.	z-score/year	LEAST_SQUARES_MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group264

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

Outcome	Group	Value	Spread	Units
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score	Atenolol	-0.139	Standard Error 0.013	z-score/year
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score	Losartan	-0.107	Standard Error 0.013	z-score/year
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension	Atenolol	0.069	Standard Error 0.004	cm/year
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension	Losartan	0.075	Standard Error 0.004	cm/year
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.	Atenolol	-0.140	Standard Error 0.013	z-score/year
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.	Losartan	-0.114	Standard Error 0.013	z-score/year
Annual Rate of Change in the Absolute Diameter of the Ascending Aorta	Atenolol	0.039	Standard Error 0.004	cm/year
Annual Rate of Change in the Absolute Diameter of the Ascending Aorta	Losartan	0.044	Standard Error 0.004	cm/year
Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area	Atenolol	-0.279	Standard Error 0.018	z-score/year
Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area	Losartan	-0.175	Standard Error 0.018	z-score/year

1 to 10 of 264Source ClinicalTrials.gov

See all 264 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Atenolol	303
Overall Study	STARTED	Losartan	305
Overall Study	COMPLETED	Atenolol	271
Overall Study	COMPLETED	Losartan	272
Overall Study	NOT COMPLETED	Atenolol	32
Overall Study	NOT COMPLETED	Losartan	33

Source ClinicalTrials.gov

Adverse events444

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	Anemia	Blood and lymphatic system disorders	Atenolol	0	303	0
other	Anemia	Blood and lymphatic system disorders	Losartan	1	305	1
other	Haemoglobin	Blood and lymphatic system disorders	Atenolol	0	303	0
other	Haemoglobin	Blood and lymphatic system disorders	Losartan	2	305	2
other	Lymph node pain	Blood and lymphatic system disorders	Atenolol	1	303	1
other	Lymph node pain	Blood and lymphatic system disorders	Losartan	0	305	0
other	Cardiac General - Other - Murmur	Cardiac disorders	Atenolol	0	303	0
other	Cardiac General - Other - Murmur	Cardiac disorders	Losartan	1	305	1
other	Cardiac General - other - nonresponsive and pale	Cardiac disorders	Atenolol	1	303	1
other	Cardiac General - other - nonresponsive and pale	Cardiac disorders	Losartan	0	305	0

1 to 10 of 444Source ClinicalTrials.gov

See all 444 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atenolol
Total, all-cause mortality	Losartan
Total, other adverse events	Atenolol	135	303
Total, other adverse events	Losartan	121	305
Total, serious adverse events	Atenolol	27	303
Total, serious adverse events	Losartan	33	305

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23622922	DERIVED	PubMed
25405392	DERIVED	PubMed
29948025	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL068270	Pediatric Heart Network: Data Coordinating Center	SLEEPER, LYNN A	NEW ENGLAND RESEARCH INSTITUTES, INC.	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2001 to 2010

Source NIH RePORTER

Trial comparisons5

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

Comparison	Source
Atenolol vs Losartan: Number of Death.	Trial comparisons
Atenolol vs Losartan: Number of Participants With Aortic-root Surgery.	Trial comparisons
Atenolol vs Losartan: Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.	Trial comparisons
Atenolol vs Losartan: Number of Participants With Aortic Dissection.	Trial comparisons
Atenolol vs Losartan: 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/NCT00429364

GET https://conductscience.org/api/trials/v1/NCT00429364/registered?page=2

API reference For AI assistants