Trial Outcomes & Findings for Sex and Obesity: Effects on Heart Failure Study (NCT NCT00776035)
NCT ID: NCT00776035
Last Updated: 2024-05-03
Results Overview
Myocardial blood flow (MBF) was measured using \^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
COMPLETED
19 participants
Study Day 2
2024-05-03
Participant Flow
Participants with nonischemic heart failure
Participant milestones
| Measure |
Men With Heart Failure
Men with obesity-related heart failure
|
Women With Heart Failure
Women with obesity-related heart failure
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex and Obesity: Effects on Heart Failure Study
Baseline characteristics by cohort
| Measure |
Men With Heart Failure
n=9 Participants
Men with obesity-related heart failure
|
Women With Heart Failure
n=10 Participants
Women with obesity-related heart failure
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 3 • n=99 Participants
|
41 years
STANDARD_DEVIATION 3 • n=107 Participants
|
41.5 years
STANDARD_DEVIATION 9.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Homeostasis model assessment of insulin resistance
|
2.55 units on a scale
STANDARD_DEVIATION 0.51 • n=99 Participants
|
4.40 units on a scale
STANDARD_DEVIATION 1.77 • n=107 Participants
|
3.52 units on a scale
STANDARD_DEVIATION 4.19 • n=206 Participants
|
|
Body Mass Index (BMI)
|
31 kg/m^2
STANDARD_DEVIATION 2 • n=99 Participants
|
35 kg/m^2
STANDARD_DEVIATION 8 • n=107 Participants
|
32.96 kg/m^2
STANDARD_DEVIATION 7.54 • n=206 Participants
|
PRIMARY outcome
Timeframe: Study Day 2Population: Participants who completed the PET scan assessment
Myocardial blood flow (MBF) was measured using \^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Outcome measures
| Measure |
Men With Heart Failure
n=9 Participants
Men with obesity-related heart failure
|
Women With Heart Failure
n=10 Participants
Women with obesity-related heart failure
|
|---|---|---|
|
Average Myocardial Blood Flow
|
0.73 mL/g/minute
Standard Deviation 0.17
|
0.97 mL/g/minute
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Study Day 2Population: Participants who completed the PET assessment
Myocardial fatty acid (FA) utilization was measured using 1-\^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Outcome measures
| Measure |
Men With Heart Failure
n=9 Participants
Men with obesity-related heart failure
|
Women With Heart Failure
n=10 Participants
Women with obesity-related heart failure
|
|---|---|---|
|
Average Myocardial Fatty Acid Utilization
|
85 nmol/g/minute
Standard Deviation 26
|
139 nmol/g/minute
Standard Deviation 68
|
Adverse Events
Men With Heart Failure
Women With Heart Failure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Linda R. Peterson, MD, Professor of Medicine and Radiology
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place