Trial Outcomes & Findings for Impact of Diabetes on Left Ventricular Remodeling (NCT NCT01052272)
NCT ID: NCT01052272
Last Updated: 2012-12-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
72 participants
Primary outcome timeframe
5 visits per Participant over 2 years (about every 6 months)
Results posted on
2012-12-17
Participant Flow
Participant milestones
| Measure |
Ramipril
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.
|
Candesartan Cilexetil
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.
|
Ramipril and Allopurinol
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.
|
Candesartan Cilexetil and Allopurinol
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 Study
STARTED
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
13
|
11
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
8
|
7
|
Reasons for withdrawal
| Measure |
Ramipril
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.
|
Candesartan Cilexetil
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.
|
Ramipril and Allopurinol
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.
|
Candesartan Cilexetil and Allopurinol
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 Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
patient refuses follow-up
|
5
|
4
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
3
|
2
|
|
Overall Study
placed in long-term care
|
0
|
0
|
1
|
0
|
|
Overall Study
decline in health
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Impact of Diabetes on Left Ventricular Remodeling
Baseline characteristics by cohort
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
58.17 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
60.94 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
60.67 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10.86 • n=4 Participants
|
60.44 years
STANDARD_DEVIATION 10.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
18 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 15(n=3,2,1,1)
|
81.19 ml/m^2
Standard Deviation 5.96
|
90.20 ml/m^2
Standard Deviation 13.24
|
108.25 ml/m^2
Standard Deviation NA
n=1
|
63.1 ml/m^2
Standard Deviation NA
n=1
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 21(n=3,0,0,1)
|
71.99 ml/m^2
Standard Deviation 28.13
|
NA ml/m^2
Standard Deviation NA
n=0
|
NA ml/m^2
Standard Deviation NA
n=0
|
75.27 ml/m^2
Standard Deviation NA
n=1
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 24 (n=11,9,8,10)
|
70.46 ml/m^2
Standard Deviation 17.17
|
84.28 ml/m^2
Standard Deviation 23.17
|
71.63 ml/m^2
Standard Deviation 8.59
|
79.72 ml/m^2
Standard Deviation 15.11
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 0 (n=17,17,18,18)
|
73.03 ml/m^2
Standard Deviation 20.34
|
78.06 ml/m^2
Standard Deviation 18.4
|
78.52 ml/m^2
Standard Deviation 19.31
|
79.03 ml/m^2
Standard Deviation 21.39
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 6(n=14,11,11,12)
|
74.10 ml/m^2
Standard Deviation 15.53
|
78.60 ml/m^2
Standard Deviation 24.30
|
86.13 ml/m^2
Standard Deviation 24.14
|
78.01 ml/m^2
Standard Deviation 14.49
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 9(n=1,2,0,0)
|
73.23 ml/m^2
Standard Deviation NA
n=1
|
93.57 ml/m^2
Standard Deviation 18.48
|
NA ml/m^2
Standard Deviation NA
n=0
|
NA ml/m^2
Standard Deviation NA
n=0
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month12(n=12,11,11,11)
|
75.34 ml/m^2
Standard Deviation 20.30
|
85.44 ml/m^2
Standard Deviation 20.87
|
83.95 ml/m^2
Standard Deviation 20.69
|
79.75 ml/m^2
Standard Deviation 19.9
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 18(n=10,12,8,8)
|
75.28 ml/m^2
Standard Deviation 14.48
|
82.74 ml/m^2
Standard Deviation 23.09
|
67.96 ml/m^2
Standard Deviation 12.86
|
84.95 ml/m^2
Standard Deviation 17.55
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)
Month 27 (n=1,1,0,1)
|
48.68 ml/m^2
Standard Deviation NA
n=1
|
76.65 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
n=0
|
75.05 ml/m^2
Standard Deviation NA
n=1
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 9(n=1,2,0,0)
|
3.42 unitless
Standard Deviation NA
n=1
|
4.14 unitless
Standard Deviation 0.84
|
NA unitless
Standard Deviation NA
n=0
|
NA unitless
Standard Deviation NA
n=0
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 15(n=3,2,1,1)
|
3.44 unitless
Standard Deviation 0.56
|
4.10 unitless
Standard Deviation 1.10
|
4.57 unitless
Standard Deviation NA
n=1
|
3.90 unitless
Standard Deviation NA
n=1
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 21(n=3,0,0,1)
|
2.92 unitless
Standard Deviation 0.43
|
NA unitless
Standard Deviation NA
n=0
|
NA unitless
Standard Deviation NA
n=0
|
4.24 unitless
Standard Deviation NA
n=1
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 27 (n=1,1,0,1)
|
3.12 unitless
Standard Deviation NA
n=1
|
4.04 unitless
Standard Deviation NA
n=1
|
NA unitless
Standard Deviation NA
n=0
|
4.29 unitless
Standard Deviation NA
n=1
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 0 (n=17,17,18,18)
|
3.23 unitless
Standard Deviation 0.77
|
3.14 unitless
Standard Deviation 0.79
|
3.57 unitless
Standard Deviation 0.98
|
3.45 unitless
Standard Deviation 0.61
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 6(n=14,11,11,12)
|
3.32 unitless
Standard Deviation 0.70
|
3.39 unitless
Standard Deviation 0.44
|
4.04 unitless
Standard Deviation 0.75
|
3.63 unitless
Standard Deviation 0.61
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 12(n=12,11,11,11)
|
3.43 unitless
Standard Deviation 0.71
|
3.68 unitless
Standard Deviation 0.68
|
4.01 unitless
Standard Deviation 0.71
|
3.42 unitless
Standard Deviation 0.47
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 18(n=10,12,8,8)
|
3.60 unitless
Standard Deviation 0.69
|
3.71 unitless
Standard Deviation 0.76
|
3.60 unitless
Standard Deviation 0.55
|
3.56 unitless
Standard Deviation 0.48
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)
Month 24 (n=11,9,8,10)
|
3.46 unitless
Standard Deviation 0.74
|
3.58 unitless
Standard Deviation 0.69
|
3.61 unitless
Standard Deviation 0.57
|
3.56 unitless
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 12(n=12,11,11,11)
|
0.84 g/ml
Standard Deviation 0.18
|
0.78 g/ml
Standard Deviation 0.19
|
0.72 g/ml
Standard Deviation 0.15
|
0.86 g/ml
Standard Deviation 0.13
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 24 (n=11,9,8,10)
|
0.84 g/ml
Standard Deviation 0.18
|
0.80 g/ml
Standard Deviation 0.20
|
0.80 g/ml
Standard Deviation 0.14
|
0.82 g/ml
Standard Deviation 0.08
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 0 (n=17,17,18,18)
|
0.92 g/ml
Standard Deviation 0.25
|
0.95 g/ml
Standard Deviation 0.27
|
0.86 g/ml
Standard Deviation 0.26
|
0.87 g/ml
Standard Deviation 0.13
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 6(n=14,11,11,12)
|
0.87 g/ml
Standard Deviation 0.18
|
0.83 g/ml
Standard Deviation 0.13
|
0.71 g/ml
Standard Deviation 0.17
|
0.82 g/ml
Standard Deviation 0.12
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 9(n=1,2,0,0)
|
0.75 g/ml
Standard Deviation NA
n=1
|
0.67 g/ml
Standard Deviation 0.11
|
NA g/ml
Standard Deviation NA
n=0
|
NA g/ml
Standard Deviation NA
n=0
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 15(n=3,2,1,1)
|
0.81 g/ml
Standard Deviation 0.16
|
0.70 g/ml
Standard Deviation 0.18
|
0.57 g/ml
Standard Deviation NA
n=1
|
0.68 g/ml
Standard Deviation NA
n=1
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 18(n=10,12,8,8)
|
0.79 g/ml
Standard Deviation 0.16
|
0.79 g/ml
Standard Deviation 0.22
|
0.83 g/ml
Standard Deviation 0.16
|
0.80 g/ml
Standard Deviation 0.12
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 21(n=3,0,0,1)
|
0.95 g/ml
Standard Deviation 0.25
|
NA g/ml
Standard Deviation NA
n=0
|
NA g/ml
Standard Deviation NA
n=0
|
0.69 g/ml
Standard Deviation NA
n=1
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)
Month 27 (n=1,1,0,1)
|
0.93 g/ml
Standard Deviation NA
n=1
|
0.64 g/ml
Standard Deviation NA
n=1
|
NA g/ml
Standard Deviation NA
n=0
|
0.69 g/ml
Standard Deviation NA
n=1
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
Month 0 (n=17,17,18,18)
|
52.19 percent
Standard Deviation 10.65
|
56.36 percent
Standard Deviation 12.34
|
53.37 percent
Standard Deviation 10.01
|
52.68 percent
Standard Deviation 13.90
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 6(n=14,11,11,12)
|
54.20 percent
Standard Deviation 10.27
|
56.82 percent
Standard Deviation 10.81
|
52.80 percent
Standard Deviation 15.66
|
57.28 percent
Standard Deviation 9.17
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 15(n=3,2,1,1)
|
52.13 percent
Standard Deviation 14.08
|
39.88 percent
Standard Deviation 2.76
|
34.89 percent
Standard Deviation NA
n=1
|
54.46 percent
Standard Deviation NA
n=1
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 9(n=1,2,0,0)
|
64.98 percent
Standard Deviation NA
n=1
|
42.62 percent
Standard Deviation 1.95
|
NA percent
Standard Deviation NA
n=0
|
NA percent
Standard Deviation NA
n=0
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 12(n=12,11,11,11)
|
52.76 percent
Standard Deviation 9.94
|
52.37 percent
Standard Deviation 11.41
|
51.74 percent
Standard Deviation 15.54
|
56.11 percent
Standard Deviation 11.33
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 18(n=10,12,8,8)
|
55.02 percent
Standard Deviation 13.24
|
56.33 percent
Standard Deviation 10.26
|
54.05 percent
Standard Deviation 9.96
|
57.82 percent
Standard Deviation 10.97
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 21(n=3,0,0,1)
|
51.27 percent
Standard Deviation 1.73
|
NA percent
Standard Deviation NA
n=0
|
NA percent
Standard Deviation NA
n=0
|
56.17 percent
Standard Deviation NA
n=1
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 24 (n=11,9,8,10)
|
57.18 percent
Standard Deviation 9.79
|
51.70 percent
Standard Deviation 10.02
|
55.59 percent
Standard Deviation 9.47
|
55.79 percent
Standard Deviation 10.53
|
|
Left Ventricular Ejection Fraction (LVEF)
Month 27 (n=1,1,0,1)
|
50.73 percent
Standard Deviation NA
n=1
|
54.17 percent
Standard Deviation NA
n=1
|
NA percent
Standard Deviation NA
n=0
|
54.40 percent
Standard Deviation NA
n=1
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 0 (n=17,17,18,18)
|
36.20 ml/m^2
Standard Deviation 16.64
|
35.26 ml/m^2
Standard Deviation 16.08
|
37.91 ml/m^2
Standard Deviation 16.63
|
39.49 ml/m^2
Standard Deviation 21.97
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 6(n=14,11,11,12)
|
34.77 ml/m^2
Standard Deviation 13.56
|
35.26 ml/m^2
Standard Deviation 18.36
|
42.88 ml/m^2
Standard Deviation 25.33
|
34.15 ml/m^2
Standard Deviation 12.80
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 12(n=12,11,11,11)
|
36.82 ml/m^2
Standard Deviation 15.88
|
42.27 ml/m^2
Standard Deviation 19.83
|
42.34 ml/m^2
Standard Deviation 25.18
|
36.07 ml/m^2
Standard Deviation 16.24
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 24 (n=11,9,8,10)
|
31.17 ml/m^2
Standard Deviation 14.47
|
41.72 ml/m^2
Standard Deviation 18.48
|
31.56 ml/m^2
Standard Deviation 6.52
|
35.99 ml/m^2
Standard Deviation 13.65
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 27 (n=1,1,0,1)
|
23.98 ml/m^2
Standard Deviation NA
n=1
|
35.13 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
n=0
|
34.22 ml/m^2
Standard Deviation NA
n=1
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 9(n=1,2,0,0)
|
25.64 ml/m^2
Standard Deviation NA
n=1
|
53.87 ml/m^2
Standard Deviation 12.43
|
NA ml/m^2
Standard Deviation NA
n=0
|
NA ml/m^2
Standard Deviation NA
n=0
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 15(n=3,2,1,1)
|
39.42 ml/m^2
Standard Deviation 14.05
|
54.04 ml/m^2
Standard Deviation 5.47
|
70.48 ml/m^2
Standard Deviation NA
n=1
|
28.74 ml/m^2
Standard Deviation NA
n=1
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 18(n=10,12,8,8)
|
35.30 ml/m^2
Standard Deviation 17.21
|
37.76 ml/m^2
Standard Deviation 18.48
|
30.39 ml/m^2
Standard Deviation 4.61
|
37.18 ml/m^2
Standard Deviation 15.95
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)
Month 21(n=3,0,0,1)
|
35.23 ml/m^2
Standard Deviation 14.52
|
NA ml/m^2
Standard Deviation NA
n=0
|
NA ml/m^2
Standard Deviation NA
n=0
|
32.99 ml/m^2
Standard Deviation NA
n=1
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 0 (n=17,17,17,18)
|
15.81 percent of length at end of filling
Standard Deviation 3.56
|
16.68 percent of length at end of filling
Standard Deviation 3.12
|
15.84 percent of length at end of filling
Standard Deviation 2.70
|
16.00 percent of length at end of filling
Standard Deviation 2.77
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 6(n=14,11,10,12)
|
16.88 percent of length at end of filling
Standard Deviation 1.90
|
17.50 percent of length at end of filling
Standard Deviation 2.07
|
18.72 percent of length at end of filling
Standard Deviation 2.4
|
18.50 percent of length at end of filling
Standard Deviation 2.0
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 9(n=1,2,0,0)
|
18.43 percent of length at end of filling
Standard Deviation NA
n=1
|
19.08 percent of length at end of filling
Standard Deviation 2.78
|
NA percent of length at end of filling
Standard Deviation NA
n=0
|
NA percent of length at end of filling
Standard Deviation NA
n=0
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 12(n=11,11,10,10)
|
14.57 percent of length at end of filling
Standard Deviation 2.91
|
17.13 percent of length at end of filling
Standard Deviation 1.94
|
17.96 percent of length at end of filling
Standard Deviation 1.68
|
18.51 percent of length at end of filling
Standard Deviation 2.41
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 15(n=3,2,1,1)
|
17.06 percent of length at end of filling
Standard Deviation 1.83
|
16.28 percent of length at end of filling
Standard Deviation 2.42
|
14.22 percent of length at end of filling
Standard Deviation NA
n=1
|
16.36 percent of length at end of filling
Standard Deviation NA
n=1
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 18(n=10,12,7,8)
|
17.26 percent of length at end of filling
Standard Deviation 1.46
|
17.55 percent of length at end of filling
Standard Deviation 1.62
|
17.46 percent of length at end of filling
Standard Deviation 1.19
|
17.52 percent of length at end of filling
Standard Deviation 1.6
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 21(n=3,0,0,1)
|
16.68 percent of length at end of filling
Standard Deviation 1.27
|
NA percent of length at end of filling
Standard Deviation NA
n=0
|
NA percent of length at end of filling
Standard Deviation NA
n=0
|
17.89 percent of length at end of filling
Standard Deviation NA
n=1
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 24 (n=11,9,8,10)
|
15.67 percent of length at end of filling
Standard Deviation 3.36
|
16.62 percent of length at end of filling
Standard Deviation 1.32
|
17.52 percent of length at end of filling
Standard Deviation 1.17
|
17.85 percent of length at end of filling
Standard Deviation 1.37
|
|
LV End Systolic Maximum Shortening (LVES Max Shortening)
Month 27 (n=1,1,0,1)
|
13.70 percent of length at end of filling
Standard Deviation NA
n=1
|
20.38 percent of length at end of filling
Standard Deviation NA
n=0
|
NA percent of length at end of filling
Standard Deviation NA
n=0
|
16.59 percent of length at end of filling
Standard Deviation NA
n=1
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
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.
Outcome measures
| Measure |
Ramipril
n=18 Participants
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.
|
Candesartan Cilexetil
n=18 Participants
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.
|
Ramipril and Allopurinol
n=18 Participants
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.
|
Candesartan Cilexetil and Allopurinol
n=18 Participants
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.
|
|---|---|---|---|---|
|
Peak Early Filling Rate Normalized to EDV
Month 12(n=12,11,11,11)
|
1.80 1/sec
Standard Deviation 0.60
|
1.90 1/sec
Standard Deviation 0.71
|
1.93 1/sec
Standard Deviation 0.45
|
1.77 1/sec
Standard Deviation 0.83
|
|
Peak Early Filling Rate Normalized to EDV
Month 15(n=3,2,1,1)
|
2.02 1/sec
Standard Deviation 1.09
|
1.48 1/sec
Standard Deviation 0.58
|
1.56 1/sec
Standard Deviation NA
n=1
|
2.28 1/sec
Standard Deviation NA
n=1
|
|
Peak Early Filling Rate Normalized to EDV
Month 0 (n=17,17,18,18)
|
1.93 1/sec
Standard Deviation 0.69
|
2.01 1/sec
Standard Deviation 0.76
|
2.11 1/sec
Standard Deviation 0.56
|
2.0 1/sec
Standard Deviation 0.74
|
|
Peak Early Filling Rate Normalized to EDV
Month 6(n=14,11,11,12)
|
1.74 1/sec
Standard Deviation 0.77
|
2.02 1/sec
Standard Deviation 0.81
|
2.03 1/sec
Standard Deviation 0.95
|
1.98 1/sec
Standard Deviation 0.73
|
|
Peak Early Filling Rate Normalized to EDV
Month 9(n=1,2,0,0)
|
2.50 1/sec
Standard Deviation NA
n=1
|
1.13 1/sec
Standard Deviation 0.83
|
NA 1/sec
Standard Deviation NA
n=0
|
NA 1/sec
Standard Deviation NA
n=0
|
|
Peak Early Filling Rate Normalized to EDV
Month 18(n=10,12,8,8)
|
1.91 1/sec
Standard Deviation 0.52
|
1.93 1/sec
Standard Deviation 0.84
|
1.89 1/sec
Standard Deviation 0.78
|
2.05 1/sec
Standard Deviation 0.59
|
|
Peak Early Filling Rate Normalized to EDV
Month 21(n=3,0,0,1)
|
1.69 1/sec
Standard Deviation 0.42
|
NA 1/sec
Standard Deviation NA
n=0
|
NA 1/sec
Standard Deviation NA
n=0
|
2.50 1/sec
Standard Deviation NA
n=1
|
|
Peak Early Filling Rate Normalized to EDV
Month 24 (n=11,9,8,10)
|
2.05 1/sec
Standard Deviation 0.81
|
1.65 1/sec
Standard Deviation 0.55
|
1.88 1/sec
Standard Deviation 0.50
|
1.82 1/sec
Standard Deviation 0.78
|
|
Peak Early Filling Rate Normalized to EDV
Month 27 (n=1,1,0,1)
|
1.34 1/sec
Standard Deviation NA
n=1
|
1.10 1/sec
Standard Deviation NA
n=1
|
NA 1/sec
Standard Deviation NA
n=0
|
2.15 1/sec
Standard Deviation NA
n=1
|
Adverse Events
Ramipril
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Candesartan Cilexetil
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Ramipril and Allopurinol
Serious events: 9 serious events
Other events: 6 other events
Deaths: 0 deaths
Candesartan Cilexetil and Allopurinol
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramipril
n=18 participants at risk
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.
|
Candesartan Cilexetil
n=18 participants at risk
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.
|
Ramipril and Allopurinol
n=18 participants at risk
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.
|
Candesartan Cilexetil and Allopurinol
n=18 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
cardiac catheterization performed
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
left above-knee amputation related to occlusion of his left external iliac artery
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Cardiac disorders
coronary artery bypass grafting
|
5.9%
1/17 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
hospitalized for chest pain; no surgical intervention
|
5.9%
1/17 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
0.00%
0/18
|
|
Vascular disorders
hospitalized for elective abdominal aortogram
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
hospitalized for a critically high PT/INR
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
hospitalized due to chest pain; depressed TSH of 0.009 and hematocrit of 22 with a negative hemocult
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
hospitalized for prophylactic ICD implantation
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
death due to cardiac arrest
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
chronic anemia
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
hospitalized --paroxysmal atrial fibrillation, acute gouty arthritis, chronic renal failure
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
hospitalized for anterior cervical discectomy of C5-C6
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
hospitalized for hematuria brought on by cystoscopy and right ureteroscopy
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
hospitalized for pneumonia and acute exudative tonsillitis
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
hospitalized for acute pyelonephritis
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
hospitalized for fever, cough, and general malaise; Hemodialysis was performed twice
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
infection resulting to altered mental status; episode of major depression; renal failure
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
death due to heart failure and renal failure
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
adenocarcinoma of the pancreas
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
elevated WBC; Chest x-ray revealed pleural thickening; cultures revealed klebsiella oxytoca
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
acute anterior left middle cerebral artery distribution infarction
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
aortic valve replacement
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
coronary artery stent
|
0.00%
0/18
|
16.7%
3/18 • Number of events 3
|
0.00%
0/18
|
0.00%
0/18
|
|
General disorders
enterococcus endocarditis; ischemic right leg and GI bleed.
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Cardiac disorders
adenosine MIBI GXT positive for ischemic heart disease
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Cardiac disorders
coronary angioplasty
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Nervous system disorders
episode of slurred speech and memory loss at home
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Renal and urinary disorders
acute renal failure
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
Other adverse events
| Measure |
Ramipril
n=18 participants at risk
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.
|
Candesartan Cilexetil
n=18 participants at risk
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.
|
Ramipril and Allopurinol
n=18 participants at risk
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.
|
Candesartan Cilexetil and Allopurinol
n=18 participants at risk
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.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
WORSENING RIGHT HIP
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
worsening lower back pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
abdominal cramping
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
increased shortness of breath
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
STERNOTOMY MUSCULOSKELETAL PAIN
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Renal and urinary disorders
ACUTE RENAL INSUFFICIENCY
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
CHEST WALL PAIN
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
BILATERAL HIP ARTHRITIS
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
INTOLERANCE TO ACE-I
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Renal and urinary disorders
GOUT
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Eye disorders
CATARACT REPAIR LEFT EYE
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
LOWER PAIN
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
HYPERKALEMIA
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
|
Cardiac disorders
SEVERE AORTIC REGURGITATION
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE BRONCHITIS
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Renal and urinary disorders
placement of AV fistula
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Additional Information
Louis . J. Dell'Italia, M.D
University of Alabama at Birmingham
Phone: 205-934-3969
Email: Dell'[email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place