Trial · NCT01715207
Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS
NCT01715207, Phase 3, Completed, Samsung Medical Center; results first posted 2017-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS. Trials, record NCT01715207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01715207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS
- NCT number
- NCT01715207
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Samsung Medical Center
- Conditions
- Marfan Syndrome
- Interventions
- Aliskiren, Atenolol
- First posted
- 2012-10-26
- Last updated
- 2017-06-05
- Results first posted
- 2017-05-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Central Aortic Distensibility by MRI | 6 months | Analyses of the MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems, Germany) by experienced observers who were blinded to patient information. To measure central aortic distensibility, the systolic and diastolic cross-sectional areas were measured by manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at the four regions was calculated as the mean of values obtained from the following equation: Distensibility = (Amax - Amin)/\[Amin × (Pmax - Pmin)\](10-3mm/Hg), where Amax is the maximal (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood pressure. |
| Secondary | Central Aortic PWV(Pulsed Wave Velocity) | 6 months | Aortic PWV was measured according to the well-validated method using MRI 19. From the velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in each slice area throughout the cardiac cycle. The transit time between the flow curves of each region of the aorta was determined from the midpoint of the systolic up-slope on the flow versus time curve 26-28. The up-slopes were identified by drawing a line between the points of 40% and 60% maximum velocity on the waveform. The distance between each aortic level was measured on black blood images using a curved line along the center of the aorta. Based on these data, the regional PWV was calculated as the ratio of the distance between levels and the time differences between the arrival of the pulse wave at each level. The PWV was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2) and the entire aorta (PWV-total between level 1 and level 4). |
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 | Central Aortic Distensibility by MRI | 6 months | MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy. | (mmHg ^ -1) x 10 ^ -3 | MEAN |
| SECONDARY | Central Aortic PWV(Pulsed Wave Velocity) | 6 months | MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy. | m/s | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Central Aortic Distensibility by MRI | Atenolol & Aliskiren | initial ascending aorta | 3.7 | Standard Deviation 1.3 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol | initial ascending aorta | 4.7 | Standard Deviation 2.8 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol & Aliskiren | initial upper descending aorta | 5.7 | Standard Deviation 1.8 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol | initial upper descending aorta | 5.1 | Standard Deviation 2.5 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol & Aliskiren | initial lower descending aorta | 7.5 | Standard Deviation 2.7 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol | initial lower descending aorta | 6.3 | Standard Deviation 2.7 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol & Aliskiren | initial abdominal aorta | 2.4 | Standard Deviation 1.7 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol | initial abdominal aorta | 2.7 | Standard Deviation 1.3 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol & Aliskiren | follow up ascending aorta | 5.2 | Standard Deviation 2.7 | (mmHg ^ -1) x 10 ^ -3 |
| Central Aortic Distensibility by MRI | Atenolol | follow up ascending aorta | 5.0 | Standard Deviation 2.9 | (mmHg ^ -1) x 10 ^ -3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atenolol & Aliskiren | 15 | |
| Overall Study | STARTED | Atenolol | 15 | |
| Overall Study | COMPLETED | Atenolol & Aliskiren | 14 | |
| Overall Study | COMPLETED | Atenolol | 14 | |
| Overall Study | NOT COMPLETED | Atenolol & Aliskiren | 1 | |
| Overall Study | NOT COMPLETED | Atenolol | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | generalized symptoms | General disorders | Atenolol & Aliskiren | 8 | 14 | 8 |
| other | generalized symptoms | General disorders | Atenolol | 4 | 14 | 4 |
| serious | pneumothorax | Respiratory, thoracic and mediastinal disorders | Atenolol & Aliskiren | 1 | 14 | 1 |
| serious | pneumothorax | Respiratory, thoracic and mediastinal disorders | Atenolol | 0 | 14 | 0 |
| serious | inguinal hernia | Gastrointestinal disorders | Atenolol & Aliskiren | 1 | 14 | 1 |
| serious | inguinal hernia | Gastrointestinal disorders | Atenolol | 0 | 14 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atenolol & Aliskiren | ||
| Total, all-cause mortality | Atenolol | ||
| Total, other adverse events | Atenolol & Aliskiren | 8 | 14 |
| Total, other adverse events | Atenolol | 4 | 14 |
| Total, serious adverse events | Atenolol & Aliskiren | 2 | 14 |
| Total, serious adverse events | Atenolol | 0 | 14 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atenolol & Aliskiren vs Atenolol: serious adverse events |
Source 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.
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/NCT01715207
GET https://conductscience.org/api/trials/v1/NCT01715207/results?page=2