Marfan SyndromePhase 3NCT00429364
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome
A Phase 3 study testing Losartan Potassium and Atenolol in people with Marfan Syndrome, run by Carelon Research at 26 sites in 3 countries.
Trial summary
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities. This study will compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root enlargement in individuals with Marfan… Read more about this study
- Who is it for?
- Ages 6 months to 25 years
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Losartan Potassium and Atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Jan 2007to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Marfan syndrome, according to Ghent criteria (more information can be found in Appendix D of the protocol)
- Aortic root Z-score greater than 3.0
Who cannot join
- Prior aortic surgery
- Aortic root dimension at the sinuses of Valsalva greater than 5 cm
- Planned aortic surgery within 6 months of study entry
- Aortic dissection
- Shprintzen-Goldberg syndrome
- Loeys-Dietz syndrome
Show all 16Show fewer
- Therapeutic (i.e., for arrhythmia, ventricular dysfunction, or valve regurgitation) rather than prophylactic use of angiotensin-converting enzyme (ACE) inhibitor, beta-blocker, or calcium channel blocker
- History of angioedema while taking an ACE inhibitor or beta-blocker
- Intolerance to losartan or other angiotensin II receptor blocker (ARB) that resulted in termination of therapy
- Intolerance to atenolol or other beta-blocker that resulted in termination of therapy
- Kidney dysfunction (i.e., creatinine greater than the upper limit of age-related normal values)
- Asthma of sufficient severity to prohibit the use of a beta-blocker
- Chronic use of steroids and/or beta-adrenergic agents with exacerbations of asthma that are frequent (averaging three or more per year) or severe (requiring hospitalization)
- Diabetes mellitus
- Pregnant or planning to become pregnant within 36 months of study entry
- Inability to complete study procedures, including history of poor acoustic windows (i.e., inability to obtain accurate measurement of aortic root)
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States24 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Texas Children's Hospital
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Weill Medical College of Cornell University
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
Columbia College of Physicians and Surgeons
New York, New York, 10032
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Minnesota - St. Paul
Saint Paul, Minnesota, 55102
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Rady Children's Hospital / UCSD
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Trial of Beta Blocker Therapy (Atenolol) Versus Angiotensin II Receptor Blocker Therapy (Losartan) in Individuals With Marfan Syndrome (A Trial Conducted by the Pediatric Heart Network)
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities. This study will compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root enlargement in individuals with Marfan syndrome.
Read the detailed description
Marfan syndrome is an inheritable disorder that affects the body's connective tissue. An abnormal protein results in connective tissue that is weaker than normal. Because connective tissue is found throughout the body, Marfan syndrome can affect many body systems, including the skeleton, eyes, nervous system, skin, lungs, heart, and blood vessels. Overall, heart and blood vessel abnormalities are the leading cause of death in individuals with Marfan syndrome. A common blood vessel abnormality associated with this disease involves the aorta, which is the large artery that carries blood away from the heart to the rest of the body. The aortic root, the portion of the aorta that is attached to the heart, may enlarge and tear or even rupture. A tear or rupture is considered a life-threatening emergency. Recent studies have shown that the medication losartan may reduce aortic root growth and improve heart function. The purpose of this study is to compare the effectiveness of losartan versus atenolol at slowing aortic root growth in individuals with Marfan syndrome.
This 3-year study will enroll individuals with Marfan syndrome. Participants will be randomly assigned to receive either losartan or atenolol on a daily basis. All participants will initially receive a low dose of their assigned medication. This dose will be gradually increased every 3 to 4 weeks until the maximum tolerated dose is reached. A continuous electrocardiogram (ECG) that monitors heart rate and activity in 24-hour intervals will be used to determine the proper dose increase for each participant. Participants will then receive the maximum tolerated dose for the remainder of the study. Study visits will occur at baseline and Months 6, 12, 24, and 36. Each study visit will include a physical examination, a medical history review, an ECG, an echocardiogram, and questionnaires. Additionally, at the baseline study visit blood will be collected for laboratory testing.
- Conditions
- Marfan Syndrome
- Being tested
- Losartan Potassium, Atenolol
- Keywords
- Aortic Root Dissection, Aortic Root Dilation, Pediatric Heart Network
- Medical subject headings
- Marfan Syndrome, Dissection, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan PotassiumDrug
Also called Cozaar
Losartan .3 - 1.4 mg/kg
AtenololDrug
Also called Tenormin
Atenolol .5 - 4 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Atenolol | Active comparator | Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate. Receives: Drug: Atenolol |
| Losartan | Active comparator | Participants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg). Receives: Drug: Losartan Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score
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
Measured: Up to 3 years following randomization.
Secondary outcomes (25)
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension
The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization
Measured: Up to 3 years following randomization.
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.
Measured: Up to 3 years following randomization.
Annual Rate of Change in the Absolute Diameter of the Ascending Aorta
Measured: Up to 3 years following randomization.
Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area
Measured: Up to 3 years following randomization.
Annual Rate of Change in the Absolute Diameter of the Aortic Annulus
Measured: Up to 3 years following randomization.
Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area
Measured: Up to 3 years following randomization.
Annual Rate of Change in Weight
Measured: Up to 3 years following randomization.
Annual Rate of Change in Weight-for-age Z-score
Measured: Up to 3 years following randomization.
Annual Rate of Change in Weight-for-height Z-score
Measured: Up to 3 years following randomization.
Annual Rate of Change in Height
Measured: Up to 3 years following randomization.
Annual Rate of Change in Height-for-age Z-score
Measured: Up to 3 years following randomization.
Annual Rate of Change in Body Mass Index
Measured: Up to 3 years following randomization.
Annual Rate of Change in Body Mass Index for Age Z-score
Measured: Up to 3 years following randomization.
Annual Rate of Change in Arm Span to Height Ratio
Measured: Up to 3 years following randomization.
Annual Rate of Change in Upper to Lower Segment Ratio
Measured: Up to 3 years following randomization.
Number of Participants With Aortic Dissection.
Measured: Up to 3 years following randomization.
Event Rate of Aortic Dissection.
Percentage of participants who had aortic dissection over a 3-year period following randomization.
Measured: Up to 3 years following randomization.
Number of Participants With Aortic-root Surgery.
Measured: Up to 3 years following randomization.
Event Rate of Aortic-Root Surgery
Percentage of participants who had aortic-root surgery over a 3-year period following randomization.
Measured: Up to 3 years following randomization.
Number of Death.
Measured: Up to 3 years following randomization.
Event Rate of Death
Percentage of participants who died over a 3-year period following randomization.
Measured: Up to 3 years following randomization.
Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
Measured: Up to 3 years following randomization.
Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization
Measured: Up to 3 years following randomization.
Adverse Drug Reactions Reported at the Baseline Visit
Measured: At baseline
Adverse Drug Reactions Reported During Routine Follow-up Surveillance
Measured: From 6 months to 3 years following randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), FDA Office of Orphan Products Development, National Marfan Foundation
- Responsible party
- Sponsor
- Investigators
- Ron Lacro, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429364
- Sponsor's protocol ID
- 461
- Other IDs
- U01HL068270
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2007
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hoskoppal A, Menon S, Trachtenberg F, Burns KM, De Backer J, Gelb BD, Gleason M, James J, Lai WW, Liou A, Mahony L, Olson AK, Pyeritz RE, Sharkey AM, Stylianou M, Wechsler SB, Young L, Levine JC, Tierney ESS, Lacro RV, Bradley TJ; Pediatric Heart Network Investigators. Predictors of Rapid Aortic Root Dilation and Referral for Aortic Surgery in Marfan Syndrome. Pediatr Cardiol. 2018 Oct;39(7):1453-1461. doi: 10.1007/s00246-018-1916-6. Epub 2018 Jun 11.
PubMed 29948025Lacro RV, Dietz HC, Sleeper LA, Yetman AT, Bradley TJ, Colan SD, Pearson GD, Selamet Tierney ES, Levine JC, Atz AM, Benson DW, Braverman AC, Chen S, De Backer J, Gelb BD, Grossfeld PD, Klein GL, Lai WW, Liou A, Loeys BL, Markham LW, Olson AK, Paridon SM, Pemberton VL, Pierpont ME, Pyeritz RE, Radojewski E, Roman MJ, Sharkey AM, Stylianou MP, Wechsler SB, Young LT, Mahony L; Pediatric Heart Network Investigators. Atenolol versus losartan in children and young adults with Marfan's syndrome. N Engl J Med. 2014 Nov 27;371(22):2061-71. doi: 10.1056/NEJMoa1404731. Epub 2014 Nov 18.
PubMed 25405392Lacro RV, Guey LT, Dietz HC, Pearson GD, Yetman AT, Gelb BD, Loeys BL, Benson DW, Bradley TJ, De Backer J, Forbus GA, Klein GL, Lai WW, Levine JC, Lewin MB, Markham LW, Paridon SM, Pierpont ME, Radojewski E, Selamet Tierney ES, Sharkey AM, Wechsler SB, Mahony L; Pediatric Heart Network Investigators. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy. Am Heart J. 2013 May;165(5):828-835.e3. doi: 10.1016/j.ahj.2013.02.019. Epub 2013 Mar 26.
PubMed 23622922
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Beta Blocker Therapy (Atenolol) Versus Angiotensin II Receptor Blocker Therapy (Losartan) in Individuals With Marfan Syndrome (A Trial Conducted by the Pediatric Heart Network)
- ClinicalTrials.gov ID
- NCT00429364
- Acronym / sponsor ID
- 461
- Conditions
- Marfan Syndrome
- Keywords
- Aortic Root Dissection, Aortic Root Dilation, Pediatric Heart Network
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), FDA Office of Orphan Products Development, National Marfan Foundation
- Study start
- Jan 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities. This study will compare the effectiveness of two medications, losartan and atenolol, at slowing aortic root enlargement in individuals with Marfan syndrome.
Detailed description
Marfan syndrome is an inheritable disorder that affects the body's connective tissue. An abnormal protein results in connective tissue that is weaker than normal. Because connective tissue is found throughout the body, Marfan syndrome can affect many body systems, including the skeleton, eyes, nervous system, skin, lungs, heart, and blood vessels. Overall, heart and blood vessel abnormalities are the leading cause of death in individuals with Marfan syndrome. A common blood vessel abnormality associated with this disease involves the aorta, which is the large artery that carries blood away from the heart to the rest of the body. The aortic root, the portion of the aorta that is attached to the heart, may enlarge and tear or even rupture. A tear or rupture is considered a life-threatening emergency. Recent studies have shown that the medication losartan may reduce aortic root growth and improve heart function. The purpose of this study is to compare the effectiveness of losartan versus atenolol at slowing aortic root growth in individuals with Marfan syndrome.
This 3-year study will enroll individuals with Marfan syndrome. Participants will be randomly assigned to receive either losartan or atenolol on a daily basis. All participants will initially receive a low dose of their assigned medication. This dose will be gradually increased every 3 to 4 weeks until the maximum tolerated dose is reached. A continuous electrocardiogram (ECG) that monitors heart rate and activity in 24-hour intervals will be used to determine the proper dose increase for each participant. Participants will then receive the maximum tolerated dose for the remainder of the study. Study visits will occur at baseline and Months 6, 12, 24, and 36. Each study visit will include a physical examination, a medical history review, an ECG, an echocardiogram, and questionnaires. Additionally, at the baseline study visit blood will be collected for laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atenolol | Active comparator | Drug: AtenololParticipants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate. |
| Losartan | Active comparator | Drug: Losartan PotassiumParticipants with Marfan's syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg). |
Who may qualify
- Ages
- 6 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of Marfan syndrome, according to Ghent criteria (more information can be found in Appendix D of the protocol)
- Aortic root Z-score greater than 3.0
Key exclusion criteria (16 listed)
- Prior aortic surgery
- Aortic root dimension at the sinuses of Valsalva greater than 5 cm
- Planned aortic surgery within 6 months of study entry
- Aortic dissection
- Shprintzen-Goldberg syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan PotassiumAlso: CozaarLosartan .3 - 1.4 mg/kg | Drug | Losartan |
| AtenololAlso: TenorminAtenolol .5 - 4 mg/kg | Drug | Atenolol |
Primary outcome
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score
Time frame: 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
25 secondary outcomes
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.
Time frame: Up to 3 years following randomization.
Annual Rate of Change in the Absolute Diameter of the Ascending Aorta
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area
Time frame: Up to 3 years following randomization.
Annual Rate of Change in the Absolute Diameter of the Aortic Annulus
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Weight
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Weight-for-age Z-score
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Weight-for-height Z-score
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Height
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Height-for-age Z-score
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Body Mass Index
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Body Mass Index for Age Z-score
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Arm Span to Height Ratio
Time frame: Up to 3 years following randomization.
Annual Rate of Change in Upper to Lower Segment Ratio
Time frame: Up to 3 years following randomization.
Number of Participants With Aortic Dissection.
Time frame: Up to 3 years following randomization.
Event Rate of Aortic Dissection.
Time frame: Up to 3 years following randomization.
Number of Participants With Aortic-root Surgery.
Time frame: Up to 3 years following randomization.
Event Rate of Aortic-Root Surgery
Time frame: Up to 3 years following randomization.
Number of Death.
Time frame: Up to 3 years following randomization.
Event Rate of Death
Time frame: Up to 3 years following randomization.
Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
Time frame: Up to 3 years following randomization.
Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.
Time frame: Up to 3 years following randomization.
Adverse Drug Reactions Reported at the Baseline Visit
Time frame: At baseline
Adverse Drug Reactions Reported During Routine Follow-up Surveillance
Time frame: From 6 months to 3 years following randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29948025Hoskoppal A, Menon S, Trachtenberg F, Burns KM, De Backer J, Gelb BD, Gleason M, James J, Lai WW, Liou A, Mahony L, Olson AK, Pyeritz RE, Sharkey AM, Stylianou M, Wechsler SB, Young L, Levine JC, Tierney ESS, Lacro RV, Bradley TJ; Pediatric Heart Network Investigators. Predictors of Rapid Aortic Root Dilation and Referral for Aortic Surgery in Marfan Syndrome. Pediatr Cardiol. 2018 Oct;39(7):1453-1461. doi: 10.1007/s00246-018-1916-6. Epub 2018 Jun 11.
- Derived from this study: PubMed 25405392Lacro RV, Dietz HC, Sleeper LA, Yetman AT, Bradley TJ, Colan SD, Pearson GD, Selamet Tierney ES, Levine JC, Atz AM, Benson DW, Braverman AC, Chen S, De Backer J, Gelb BD, Grossfeld PD, Klein GL, Lai WW, Liou A, Loeys BL, Markham LW, Olson AK, Paridon SM, Pemberton VL, Pierpont ME, Pyeritz RE, Radojewski E, Roman MJ, Sharkey AM, Stylianou MP, Wechsler SB, Young LT, Mahony L; Pediatric Heart Network Investigators. Atenolol versus losartan in children and young adults with Marfan's syndrome. N Engl J Med. 2014 Nov 27;371(22):2061-71. doi: 10.1056/NEJMoa1404731. Epub 2014 Nov 18.
- Derived from this study: PubMed 23622922Lacro RV, Guey LT, Dietz HC, Pearson GD, Yetman AT, Gelb BD, Loeys BL, Benson DW, Bradley TJ, De Backer J, Forbus GA, Klein GL, Lai WW, Levine JC, Lewin MB, Markham LW, Paridon SM, Pierpont ME, Radojewski E, Selamet Tierney ES, Sharkey AM, Wechsler SB, Mahony L; Pediatric Heart Network Investigators. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy. Am Heart J. 2013 May;165(5):828-835.e3. doi: 10.1016/j.ahj.2013.02.019. Epub 2013 Mar 26.
- Click here for the Pediatric Heart Network Web siteLink provided by the sponsor.
- Click here for the National Marfan Foundation Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Lacro, MD principal investigator
Boston Children's Hospital
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan Potassium and Atenolol in people with Marfan Syndrome, run by Carelon Research at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score (time frame: Up to 3 years following randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.