Trial · NCT00829296
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
NCT00829296, Phase 2, Phase 3, Completed, University of Chicago; results first posted 2014-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries. Trials, record NCT00829296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00829296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
- NCT number
- NCT00829296
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 70 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Hypertension, Diabetes
- Interventions
- nebivolol, Metoprolol
- First posted
- 2009-01-27
- Last updated
- 2016-02-05
- Results first posted
- 2014-11-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Central Systolic Blood Pressure (SBP) | Baseline and 26 Weeks | Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure. |
| Secondary | Change in Pulse Wave Velocity (PWV) | Baseline and 26 Weeks | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity. |
| Secondary | Change in Augmentation Index | Baseline and 26 Weeks | Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection. |
| Secondary | Change in Pulse Pressure Amplification | Baseline and 26 Weeks | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Central Systolic Blood Pressure (SBP) | Baseline and 26 Weeks | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | mmHg | MEAN |
| SECONDARY | Change in Pulse Wave Velocity (PWV) | Baseline and 26 Weeks | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | m/s | MEAN |
| SECONDARY | Change in Augmentation Index | Baseline and 26 Weeks | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | percent (%) | MEAN |
| SECONDARY | Change in Pulse Pressure Amplification | Baseline and 26 Weeks | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | ratio | 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 Central Systolic Blood Pressure (SBP) | Nebivolol | Aortic Systolic Blood Pressure at Baseline | 125.3 | Standard Deviation 8.0 | mmHg |
| Change in Central Systolic Blood Pressure (SBP) | Metoprolol | Aortic Systolic Blood Pressure at Baseline | 127.8 | Standard Deviation 8.8 | mmHg |
| Change in Central Systolic Blood Pressure (SBP) | Nebivolol | Aortic Systolic Blood Pressure at 26 Weeks | 121.6 | Standard Deviation 8.2 | mmHg |
| Change in Central Systolic Blood Pressure (SBP) | Metoprolol | Aortic Systolic Blood Pressure at 26 Weeks | 123.8 | Standard Deviation 11.1 | mmHg |
| Change in Pulse Wave Velocity (PWV) | Nebivolol | Pulse wave velocity at Baseline | 6.48 | Standard Deviation 0.8 | m/s |
| Change in Pulse Wave Velocity (PWV) | Metoprolol | Pulse wave velocity at Baseline | 6.52 | Standard Deviation 1.2 | m/s |
| Change in Pulse Wave Velocity (PWV) | Nebivolol | Pulse wave velocity at 26 Weeks | 6.3 | Standard Deviation 0.9 | m/s |
| Change in Pulse Wave Velocity (PWV) | Metoprolol | Pulse wave velocity at 26 Weeks | 6.4 | Standard Deviation 1.3 | m/s |
| Change in Augmentation Index | Nebivolol | Augmentation index at Baseline | 22.0 | Standard Deviation 7.1 | percent (%) |
| Change in Augmentation Index | Metoprolol | Augmentation index at Baseline | 26.2 | Standard Deviation 8.3 | percent (%) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebivolol | 34 | |
| Overall Study | STARTED | Metoprolol | 36 | |
| Overall Study | COMPLETED | Nebivolol | 29 | |
| Overall Study | COMPLETED | Metoprolol | 32 | |
| Overall Study | NOT COMPLETED | Nebivolol | 5 | |
| Overall Study | NOT COMPLETED | Metoprolol | 4 |
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 | Fatigue | General disorders | Nebivolol | 2 | 34 | |
| other | Fatigue | General disorders | Metoprolol | 6 | 36 | |
| other | Diarrhea | Gastrointestinal disorders | Nebivolol | 4 | 34 | |
| other | Diarrhea | Gastrointestinal disorders | Metoprolol | 2 | 36 | |
| other | Dizziness | Nervous system disorders | Nebivolol | 2 | 34 | |
| other | Dizziness | Nervous system disorders | Metoprolol | 1 | 36 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebivolol | ||
| Total, all-cause mortality | Metoprolol | ||
| Total, other adverse events | Nebivolol | 8 | 34 |
| Total, other adverse events | Metoprolol | 9 | 36 |
| Total, serious adverse events | Nebivolol | 0 | 34 |
| Total, serious adverse events | Metoprolol | 0 | 36 |
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 |
|---|
| Nebivolol vs Metoprolol: 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/NCT00829296
GET https://conductscience.org/api/trials/v1/NCT00829296/registered