Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF (HFpEF-PRoF)
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ClinicalTrials.gov Identifier: NCT02589977 |
Recruitment Status :
Completed
First Posted : October 28, 2015
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic |
Conditions |
Heart Failure, Diastolic Diastolic Heart Failure Hypertension |
Intervention |
Drug: regadenoson |
Enrollment | 55 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Normal Participants | Hypertensive Participants | HFpEF Patients |
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No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
Period Title: Overall Study | |||
Started | 23 | 20 | 12 |
Completed | 17 | 15 | 8 |
Not Completed | 6 | 5 | 4 |
Arm/Group Title | Normal Participants | Hypertensive Participants | HFpEF Patients | Total | |
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No cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
No history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism. regadenoson: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants |
Total of all reporting groups | |
Overall Number of Baseline Participants | 17 | 15 | 8 | 40 | |
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These are the people who attended baseline visit.
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
57
(54 to 62)
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58
(54 to 65)
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69
(62 to 73)
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58
(55 to 67)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
Female |
12 70.6%
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5 33.3%
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7 87.5%
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24 60.0%
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Male |
5 29.4%
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10 66.7%
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1 12.5%
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16 40.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
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Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
1 5.9%
|
0 0.0%
|
1 12.5%
|
2 5.0%
|
|
White |
16 94.1%
|
15 100.0%
|
7 87.5%
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38 95.0%
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
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0 0.0%
|
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Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants |
17 | 15 | 8 | 40 | ||
Hypertension
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
0 0.0%
|
15 100.0%
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8 100.0%
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23 57.5%
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Diabetes
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
0 0.0%
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0 0.0%
|
3 37.5%
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3 7.5%
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BMI
Median (Inter-Quartile Range) Unit of measure: Kg/m^2 |
|||||
Number Analyzed | 17 participants | 15 participants | 8 participants | 40 participants | |
26.7
(22.6 to 28.7)
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30.1
(27.8 to 35.7)
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34.2
(29.9 to 37.8)
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29.7
(25.6 to 33.0)
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Name/Title: | Marvin Kronenberg, MD |
Organization: | Vanderbilt University Medical Center |
Phone: | 615-322-2318 |
EMail: | marvin.w.kronenberg@vumc.org |
Responsible Party: | Marvin W. Kronenberg, M.D., Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT02589977 |
Other Study ID Numbers: |
141686 |
First Submitted: | August 24, 2015 |
First Posted: | October 28, 2015 |
Results First Submitted: | December 23, 2020 |
Results First Posted: | February 2, 2021 |
Last Update Posted: | February 2, 2021 |