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Trial record 1 of 2 for:    11473080 [PUBMED-IDS]
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Impact of Diabetes on Left Ventricular Remodeling (P3)

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ClinicalTrials.gov Identifier: NCT01052272
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
AstraZeneca
Information provided by (Responsible Party):
Dr. Louis J. Dell'Italia, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Ramipril
Drug: Candesartan cilexetil
Drug: Allopurinol
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Period Title: Overall Study
Started 18 18 18 18
Completed 13 11 10 11
Not Completed 5 7 8 7
Reason Not Completed
Death             0             0             1             1
Physician Decision             0             1             0             0
patient refuses follow-up             5             4             2             4
Withdrawal by Subject             0             2             3             2
placed in long-term care             0             0             1             0
decline in health             0             0             1             0
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol Total
Hide Arm/Group Description The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily. Total of all reporting groups
Overall Number of Baseline Participants 18 18 18 18 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 18 participants 18 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  66.7%
12
  66.7%
11
  61.1%
10
  55.6%
45
  62.5%
>=65 years
6
  33.3%
6
  33.3%
7
  38.9%
8
  44.4%
27
  37.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 18 participants 18 participants 72 participants
58.17  (10.61) 60.94  (11.27) 60.67  (10.57) 62  (10.86) 60.44  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 18 participants 18 participants 72 participants
Female
2
  11.1%
3
  16.7%
8
  44.4%
3
  16.7%
16
  22.2%
Male
16
  88.9%
15
  83.3%
10
  55.6%
15
  83.3%
56
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 18 participants 18 participants 72 participants
18 18 18 18 72
1.Primary Outcome
Title Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: ml/m^2
Month 0 (n=17,17,18,18) 73.03  (20.34) 78.06  (18.4) 78.52  (19.31) 79.03  (21.39)
Month 6(n=14,11,11,12) 74.10  (15.53) 78.60  (24.30) 86.13  (24.14) 78.01  (14.49)
Month 9(n=1,2,0,0) 73.23 [1]   (NA) 93.57  (18.48) NA [2]   (NA) NA [2]   (NA)
Month12(n=12,11,11,11) 75.34  (20.30) 85.44  (20.87) 83.95  (20.69) 79.75  (19.9)
Month 15(n=3,2,1,1) 81.19  (5.96) 90.20  (13.24) 108.25 [1]   (NA) 63.1 [1]   (NA)
Month 18(n=10,12,8,8) 75.28  (14.48) 82.74  (23.09) 67.96  (12.86) 84.95  (17.55)
Month 21(n=3,0,0,1) 71.99  (28.13) NA [2]   (NA) NA [2]   (NA) 75.27 [1]   (NA)
Month 24 (n=11,9,8,10) 70.46  (17.17) 84.28  (23.17) 71.63  (8.59) 79.72  (15.11)
Month 27 (n=1,1,0,1) 48.68 [1]   (NA) 76.65 [1]   (NA) NA [2]   (NA) 75.05 [1]   (NA)
[1]
n=1
[2]
n=0
2.Primary Outcome
Title Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: unitless
Month 0 (n=17,17,18,18) 3.23  (0.77) 3.14  (0.79) 3.57  (0.98) 3.45  (0.61)
Month 6(n=14,11,11,12) 3.32  (0.70) 3.39  (0.44) 4.04  (0.75) 3.63  (0.61)
Month 9(n=1,2,0,0) 3.42 [1]   (NA) 4.14  (0.84) NA [2]   (NA) NA [2]   (NA)
Month 12(n=12,11,11,11) 3.43  (0.71) 3.68  (0.68) 4.01  (0.71) 3.42  (0.47)
Month 15(n=3,2,1,1) 3.44  (0.56) 4.10  (1.10) 4.57 [1]   (NA) 3.90 [1]   (NA)
Month 18(n=10,12,8,8) 3.60  (0.69) 3.71  (0.76) 3.60  (0.55) 3.56  (0.48)
Month 21(n=3,0,0,1) 2.92  (0.43) NA [2]   (NA) NA [2]   (NA) 4.24 [1]   (NA)
Month 24 (n=11,9,8,10) 3.46  (0.74) 3.58  (0.69) 3.61  (0.57) 3.56  (0.37)
Month 27 (n=1,1,0,1) 3.12 [1]   (NA) 4.04 [1]   (NA) NA [2]   (NA) 4.29 [1]   (NA)
[1]
n=1
[2]
n=0
3.Primary Outcome
Title Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: g/ml
Month 0 (n=17,17,18,18) 0.92  (0.25) 0.95  (0.27) 0.86  (0.26) 0.87  (0.13)
Month 6(n=14,11,11,12) 0.87  (0.18) 0.83  (0.13) 0.71  (0.17) 0.82  (0.12)
Month 9(n=1,2,0,0) 0.75 [1]   (NA) 0.67  (0.11) NA [2]   (NA) NA [2]   (NA)
Month 12(n=12,11,11,11) 0.84  (0.18) 0.78  (0.19) 0.72  (0.15) 0.86  (0.13)
Month 15(n=3,2,1,1) 0.81  (0.16) 0.70  (0.18) 0.57 [1]   (NA) 0.68 [1]   (NA)
Month 18(n=10,12,8,8) 0.79  (0.16) 0.79  (0.22) 0.83  (0.16) 0.80  (0.12)
Month 21(n=3,0,0,1) 0.95  (0.25) NA [2]   (NA) NA [2]   (NA) 0.69 [1]   (NA)
Month 24 (n=11,9,8,10) 0.84  (0.18) 0.80  (0.20) 0.80  (0.14) 0.82  (0.08)
Month 27 (n=1,1,0,1) 0.93 [1]   (NA) 0.64 [1]   (NA) NA [2]   (NA) 0.69 [1]   (NA)
[1]
n=1
[2]
n=0
4.Primary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description 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
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: percent
Month 0 (n=17,17,18,18) 52.19  (10.65) 56.36  (12.34) 53.37  (10.01) 52.68  (13.90)
Month 6(n=14,11,11,12) 54.20  (10.27) 56.82  (10.81) 52.80  (15.66) 57.28  (9.17)
Month 9(n=1,2,0,0) 64.98 [1]   (NA) 42.62  (1.95) NA [2]   (NA) NA [2]   (NA)
Month 12(n=12,11,11,11) 52.76  (9.94) 52.37  (11.41) 51.74  (15.54) 56.11  (11.33)
Month 15(n=3,2,1,1) 52.13  (14.08) 39.88  (2.76) 34.89 [1]   (NA) 54.46 [1]   (NA)
Month 18(n=10,12,8,8) 55.02  (13.24) 56.33  (10.26) 54.05  (9.96) 57.82  (10.97)
Month 21(n=3,0,0,1) 51.27  (1.73) NA [2]   (NA) NA [2]   (NA) 56.17 [1]   (NA)
Month 24 (n=11,9,8,10) 57.18  (9.79) 51.70  (10.02) 55.59  (9.47) 55.79  (10.53)
Month 27 (n=1,1,0,1) 50.73 [1]   (NA) 54.17 [1]   (NA) NA [2]   (NA) 54.40 [1]   (NA)
[1]
n=1
[2]
n=0
5.Primary Outcome
Title Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: ml/m^2
Month 0 (n=17,17,18,18) 36.20  (16.64) 35.26  (16.08) 37.91  (16.63) 39.49  (21.97)
Month 6(n=14,11,11,12) 34.77  (13.56) 35.26  (18.36) 42.88  (25.33) 34.15  (12.80)
Month 9(n=1,2,0,0) 25.64 [1]   (NA) 53.87  (12.43) NA [2]   (NA) NA [2]   (NA)
Month 12(n=12,11,11,11) 36.82  (15.88) 42.27  (19.83) 42.34  (25.18) 36.07  (16.24)
Month 15(n=3,2,1,1) 39.42  (14.05) 54.04  (5.47) 70.48 [1]   (NA) 28.74 [1]   (NA)
Month 18(n=10,12,8,8) 35.30  (17.21) 37.76  (18.48) 30.39  (4.61) 37.18  (15.95)
Month 21(n=3,0,0,1) 35.23  (14.52) NA [2]   (NA) NA [2]   (NA) 32.99 [1]   (NA)
Month 24 (n=11,9,8,10) 31.17  (14.47) 41.72  (18.48) 31.56  (6.52) 35.99  (13.65)
Month 27 (n=1,1,0,1) 23.98 [1]   (NA) 35.13 [1]   (NA) NA [2]   (NA) 34.22 [1]   (NA)
[1]
n=1
[2]
n=0
6.Primary Outcome
Title LV End Systolic Maximum Shortening (LVES Max Shortening)
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: percent of length at end of filling
Month 0 (n=17,17,17,18) 15.81  (3.56) 16.68  (3.12) 15.84  (2.70) 16.00  (2.77)
Month 6(n=14,11,10,12) 16.88  (1.90) 17.50  (2.07) 18.72  (2.4) 18.50  (2.0)
Month 9(n=1,2,0,0) 18.43 [1]   (NA) 19.08  (2.78) NA [2]   (NA) NA [2]   (NA)
Month 12(n=11,11,10,10) 14.57  (2.91) 17.13  (1.94) 17.96  (1.68) 18.51  (2.41)
Month 15(n=3,2,1,1) 17.06  (1.83) 16.28  (2.42) 14.22 [1]   (NA) 16.36 [1]   (NA)
Month 18(n=10,12,7,8) 17.26  (1.46) 17.55  (1.62) 17.46  (1.19) 17.52  (1.6)
Month 21(n=3,0,0,1) 16.68  (1.27) NA [2]   (NA) NA [2]   (NA) 17.89 [1]   (NA)
Month 24 (n=11,9,8,10) 15.67  (3.36) 16.62  (1.32) 17.52  (1.17) 17.85  (1.37)
Month 27 (n=1,1,0,1) 13.70 [1]   (NA) 20.38 [2]   (NA) NA [2]   (NA) 16.59 [1]   (NA)
[1]
n=1
[2]
n=0
7.Primary Outcome
Title Peak Early Filling Rate Normalized to EDV
Hide Description 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.
Time Frame 5 visits per Participant over 2 years (about every 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description:
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
Overall Number of Participants Analyzed 18 18 18 18
Mean (Standard Deviation)
Unit of Measure: 1/sec
Month 0 (n=17,17,18,18) 1.93  (0.69) 2.01  (0.76) 2.11  (0.56) 2.0  (0.74)
Month 6(n=14,11,11,12) 1.74  (0.77) 2.02  (0.81) 2.03  (0.95) 1.98  (0.73)
Month 9(n=1,2,0,0) 2.50 [1]   (NA) 1.13  (0.83) NA [2]   (NA) NA [2]   (NA)
Month 12(n=12,11,11,11) 1.80  (0.60) 1.90  (0.71) 1.93  (0.45) 1.77  (0.83)
Month 15(n=3,2,1,1) 2.02  (1.09) 1.48  (0.58) 1.56 [1]   (NA) 2.28 [1]   (NA)
Month 18(n=10,12,8,8) 1.91  (0.52) 1.93  (0.84) 1.89  (0.78) 2.05  (0.59)
Month 21(n=3,0,0,1) 1.69  (0.42) NA [2]   (NA) NA [2]   (NA) 2.50 [1]   (NA)
Month 24 (n=11,9,8,10) 2.05  (0.81) 1.65  (0.55) 1.88  (0.50) 1.82  (0.78)
Month 27 (n=1,1,0,1) 1.34 [1]   (NA) 1.10 [1]   (NA) NA [2]   (NA) 2.15 [1]   (NA)
[1]
n=1
[2]
n=0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Hide Arm/Group Description The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily. The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
All-Cause Mortality
Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      6/18 (33.33%)      9/18 (50.00%)      5/18 (27.78%)    
Blood and lymphatic system disorders         
hospitalized for a critically high PT/INR  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
chronic anemia  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Cardiac disorders         
cardiac catheterization performed  1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
coronary artery bypass grafting  1/17 (5.88%)  1 2/18 (11.11%)  2 0/18 (0.00%)  0 1/18 (5.56%)  1
hospitalized for chest pain; no surgical intervention  1/17 (5.88%)  1 2/18 (11.11%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
hospitalized for prophylactic ICD implantation  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
death due to cardiac arrest  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
aortic valve replacement  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
coronary artery stent  0/18 (0.00%)  0 3/18 (16.67%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0
adenosine MIBI GXT positive for ischemic heart disease  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
coronary angioplasty  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders         
adenocarcinoma of the pancreas  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders         
hospitalized due to chest pain; depressed TSH of 0.009 and hematocrit of 22 with a negative hemocult  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
hospitalized --paroxysmal atrial fibrillation, acute gouty arthritis, chronic renal failure  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
hospitalized for pneumonia and acute exudative tonsillitis  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
hospitalized for fever, cough, and general malaise; Hemodialysis was performed twice  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
infection resulting to altered mental status; episode of major depression; renal failure  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
death due to heart failure and renal failure  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
enterococcus endocarditis; ischemic right leg and GI bleed.  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations         
elevated WBC; Chest x-ray revealed pleural thickening; cultures revealed klebsiella oxytoca  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders         
hospitalized for anterior cervical discectomy of C5-C6  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Nervous system disorders         
acute anterior left middle cerebral artery distribution infarction  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
episode of slurred speech and memory loss at home  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Renal and urinary disorders         
hospitalized for hematuria brought on by cystoscopy and right ureteroscopy  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
hospitalized for acute pyelonephritis  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
acute renal failure  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders         
left above-knee amputation related to occlusion of his left external iliac artery  1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
hospitalized for elective abdominal aortogram  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ramipril Candesartan Cilexetil Ramipril and Allopurinol Candesartan Cilexetil and Allopurinol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      4/18 (22.22%)      6/18 (33.33%)      3/18 (16.67%)    
Cardiac disorders         
increased shortness of breath  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
CHEST WALL PAIN  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
SEVERE AORTIC REGURGITATION  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Eye disorders         
CATARACT REPAIR LEFT EYE  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Gastrointestinal disorders         
abdominal cramping  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders         
INTOLERANCE TO ACE-I  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders         
WORSENING RIGHT HIP  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
worsening lower back pain  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
STERNOTOMY MUSCULOSKELETAL PAIN  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
BILATERAL HIP ARTHRITIS  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
LOWER PAIN  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Renal and urinary disorders         
ACUTE RENAL INSUFFICIENCY  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
GOUT  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
HYPERKALEMIA  0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
placement of AV fistula  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
ACUTE BRONCHITIS  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Louis . J. Dell'Italia, M.D
Organization: University of Alabama at Birmingham
Phone: 205-934-3969
EMail: Dell'Italia@PHYSIOLOGY.UAB.EDU
Publications:
19. American Diabetes Association: Clinical Practice Recommendations. Diabetes Care 26: (Suppl 1) 2003.
Layout table for additonal information
Responsible Party: Dr. Louis J. Dell'Italia, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01052272     History of Changes
Other Study ID Numbers: F040105007
First Submitted: January 15, 2010
First Posted: January 20, 2010
Results First Submitted: March 20, 2012
Results First Posted: December 17, 2012
Last Update Posted: December 17, 2012