Trial Outcomes & Findings for Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride (NCT NCT00424762)
NCT ID: NCT00424762
Last Updated: 2012-04-04
Results Overview
measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute
COMPLETED
PHASE4
150 participants
6 months
2012-04-04
Participant Flow
recruitment 2/05-10/06
Participant milestones
| Measure |
Rosiglitazone
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
Rosiglitazone
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
19
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Baseline characteristics by cohort
| Measure |
Rosiglitazone
n=74 Participants
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
n=76 Participants
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
57.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
76 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: completed baseline and end-of-study cardiopulmonary exercise test
measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute
Outcome measures
| Measure |
Rosiglitazone
n=54 Participants
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
n=54 Participants
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Peak Oxygen Uptake (VO2)
|
26.1 ml O2 uptake/kg fat-free mass/minute
Standard Deviation 7
|
27.6 ml O2 uptake/kg fat-free mass/minute
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: analysis limited to those with interpretable imaging data at baseline and end of study
proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)
Outcome measures
| Measure |
Rosiglitazone
n=26 Participants
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
n=23 Participants
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months
|
0.9 percentage of fat-to-water; %
Standard Deviation 0.49
|
0.85 percentage of fat-to-water; %
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthsclinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline
Outcome measures
| Measure |
Rosiglitazone
n=74 Participants
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
n=76 Participants
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Percentage of Patients Developing New or Worsening Peripheral Edema
|
54 percentage of patients
|
33 percentage of patients
|
Adverse Events
Rosiglitazone
Placebo
Serious adverse events
| Measure |
Rosiglitazone
n=74 participants at risk
4mg oral tablet once daily titrated to 8mg oral tablet once daily
|
Placebo
n=76 participants at risk
blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
|
|---|---|---|
|
Cardiac disorders
heart failure
|
4.1%
3/74 • Number of events 3 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
|
Cardiac disorders
Heart failure
|
4.1%
3/74 • Number of events 3 • 6 months
|
0.00%
0/76 • 6 months
|
|
Cardiac disorders
acute coronary syndrome
|
0.00%
0/74 • 6 months
|
2.6%
2/76 • Number of events 2 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Darren K. McGuire
University of Texas Southwestern Medical Center at Dallas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place