Trial · NCT01052272
Impact of Diabetes on Left Ventricular Remodeling
NCT01052272, Phase 2, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2012-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Impact of Diabetes on Left Ventricular Remodeling. Trials, record NCT01052272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01052272
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Diabetes on Left Ventricular Remodeling
- NCT number
- NCT01052272
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 72 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Diabetes
- Interventions
- Ramipril, Candesartan cilexetil, Allopurinol
- First posted
- 2010-01-20
- Last updated
- 2012-12-17
- Results first posted
- 2012-12-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | 5 visits per Participant over 2 years (about every 6 months) | LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals. |
| Primary | Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness) | 5 visits per Participant over 2 years (about every 6 months) | LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. |
| Primary | Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV) | 5 visits per Participant over 2 years (about every 6 months) | LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. |
| Primary | Left Ventricular Ejection Fraction (LVEF) | 5 visits per Participant over 2 years (about every 6 months) | LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes |
| Primary | Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA) | 5 visits per Participant over 2 years (about every 6 months) | LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals. |
| Primary | LV End Systolic Maximum Shortening (LVES Max Shortening) | 5 visits per Participant over 2 years (about every 6 months) | By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. |
| Primary | Peak Early Filling Rate Normalized to EDV | 5 visits per Participant over 2 years (about every 6 months) | The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | ml/m^2 | MEAN |
| PRIMARY | Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | unitless | MEAN |
| PRIMARY | Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | g/ml | MEAN |
| PRIMARY | Left Ventricular Ejection Fraction (LVEF) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | percent | MEAN |
| PRIMARY | Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | ml/m^2 | MEAN |
| PRIMARY | LV End Systolic Maximum Shortening (LVES Max Shortening) | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | percent of length at end of filling | MEAN |
| PRIMARY | Peak Early Filling Rate Normalized to EDV | 5 visits per Participant over 2 years (about every 6 months) | intent to treat | 1/sec | MEAN |
Source ClinicalTrials.gov
Results by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Ramipril | Month 0 (n=17,17,18,18) | 73.03 | Standard Deviation 20.34 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Candesartan Cilexetil | Month 0 (n=17,17,18,18) | 78.06 | Standard Deviation 18.4 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Ramipril and Allopurinol | Month 0 (n=17,17,18,18) | 78.52 | Standard Deviation 19.31 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Candesartan Cilexetil and Allopurinol | Month 0 (n=17,17,18,18) | 79.03 | Standard Deviation 21.39 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Ramipril | Month 6(n=14,11,11,12) | 74.10 | Standard Deviation 15.53 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Candesartan Cilexetil | Month 6(n=14,11,11,12) | 78.60 | Standard Deviation 24.30 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Ramipril and Allopurinol | Month 6(n=14,11,11,12) | 86.13 | Standard Deviation 24.14 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Candesartan Cilexetil and Allopurinol | Month 6(n=14,11,11,12) | 78.01 | Standard Deviation 14.49 | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Ramipril | Month 9(n=1,2,0,0) | 73.23 | Standard Deviation NA | ml/m^2 |
| Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) | Candesartan Cilexetil | Month 9(n=1,2,0,0) | 93.57 | Standard Deviation 18.48 | ml/m^2 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramipril | 18 | |
| Overall Study | STARTED | Candesartan Cilexetil | 18 | |
| Overall Study | STARTED | Ramipril and Allopurinol | 18 | |
| Overall Study | STARTED | Candesartan Cilexetil and Allopurinol | 18 | |
| Overall Study | COMPLETED | Ramipril | 13 | |
| Overall Study | COMPLETED | Candesartan Cilexetil | 11 | |
| Overall Study | COMPLETED | Ramipril and Allopurinol | 10 | |
| Overall Study | COMPLETED | Candesartan Cilexetil and Allopurinol | 11 | |
| Overall Study | NOT COMPLETED | Ramipril | 5 | |
| Overall Study | NOT COMPLETED | Candesartan Cilexetil | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events176
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 | WORSENING RIGHT HIP | Musculoskeletal and connective tissue disorders | Ramipril | 0 | 18 | 0 |
| other | WORSENING RIGHT HIP | Musculoskeletal and connective tissue disorders | Candesartan Cilexetil | 1 | 18 | 1 |
| other | WORSENING RIGHT HIP | Musculoskeletal and connective tissue disorders | Ramipril and Allopurinol | 0 | 18 | 0 |
| other | WORSENING RIGHT HIP | Musculoskeletal and connective tissue disorders | Candesartan Cilexetil and Allopurinol | 0 | 18 | 0 |
| other | worsening lower back pain | Musculoskeletal and connective tissue disorders | Ramipril | 1 | 18 | 1 |
| other | worsening lower back pain | Musculoskeletal and connective tissue disorders | Candesartan Cilexetil | 0 | 18 | 0 |
| other | worsening lower back pain | Musculoskeletal and connective tissue disorders | Ramipril and Allopurinol | 0 | 18 | 0 |
| other | worsening lower back pain | Musculoskeletal and connective tissue disorders | Candesartan Cilexetil and Allopurinol | 0 | 18 | 0 |
| other | abdominal cramping | Gastrointestinal disorders | Ramipril | 0 | 18 | 0 |
| other | abdominal cramping | Gastrointestinal disorders | Candesartan Cilexetil | 0 | 18 | 0 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramipril | ||
| Total, all-cause mortality | Candesartan Cilexetil | ||
| Total, all-cause mortality | Ramipril and Allopurinol | ||
| Total, all-cause mortality | Candesartan Cilexetil and Allopurinol | ||
| Total, other adverse events | Ramipril | 3 | 18 |
| Total, other adverse events | Candesartan Cilexetil | 4 | 18 |
| Total, other adverse events | Ramipril and Allopurinol | 6 | 18 |
| Total, other adverse events | Candesartan Cilexetil and Allopurinol | 3 | 18 |
| Total, serious adverse events | Ramipril | 4 | 18 |
| Total, serious adverse events | Candesartan Cilexetil | 6 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers39
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01052272/results?page=2