Trial Outcomes & Findings for Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF (NCT NCT02589977)
NCT ID: NCT02589977
Last Updated: 2021-02-02
Results Overview
Rest and regadenoson stress coronary flow reserve by ammonia PET. Coronary flow calculated at rest and again at stress with coronary flow reserve calculated as the ratio of stress to rest coronary flow.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
Baseline study visit
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Normal Participants
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
|
Hypertensive 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
|
HFpEF Patients
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
12
|
|
Overall Study
COMPLETED
|
17
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
Baseline characteristics by cohort
| Measure |
Normal Participants
n=17 Participants
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
|
Hypertensive Participants
n=15 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
|
HFpEF Patients
n=8 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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=93 Participants
|
58 years
n=4 Participants
|
69 years
n=27 Participants
|
58 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
15 participants
n=4 Participants
|
8 participants
n=27 Participants
|
40 participants
n=483 Participants
|
|
Hypertension
|
0 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Diabetes
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
BMI
|
26.7 kg/m^2
n=93 Participants
|
30.1 kg/m^2
n=4 Participants
|
34.2 kg/m^2
n=27 Participants
|
29.7 kg/m^2
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline study visitPopulation: Incomplete data for 18 because of either inability to complete scan OR scan quality not adequate for analysis.
Rest and regadenoson stress coronary flow reserve by ammonia PET. Coronary flow calculated at rest and again at stress with coronary flow reserve calculated as the ratio of stress to rest coronary flow.
Outcome measures
| Measure |
Normal Participants
n=10 Participants
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
|
Hypertensive Participants
n=6 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
|
HFpEF Patients
n=6 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
|
|---|---|---|---|
|
Coronary Flow Reserve
|
2.64 ratio
Interval 2.34 to 2.85
|
2.65 ratio
Interval 2.56 to 3.11
|
2.06 ratio
Interval 1.96 to 2.26
|
SECONDARY outcome
Timeframe: Baseline study visit.Population: Incomplete data for 10 because of either inability to complete scan OR scan quality not adequate for analysis.
Myocardial perfusion reserve by CMR.
Outcome measures
| Measure |
Normal Participants
n=15 Participants
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
|
Hypertensive Participants
n=12 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
|
HFpEF Patients
n=3 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
|
|---|---|---|---|
|
Myocardial Perfusion Reserve by CMR in Each Study Group.
|
2.19 ratio
Interval 1.81 to 2.64
|
1.74 ratio
Interval 1.44 to 2.59
|
1.29 ratio
Interval 1.11 to 1.32
|
SECONDARY outcome
Timeframe: Baseline study visitPopulation: Incomplete data for 9 because of either inability to complete scan OR scan quality not adequate for analysis.
Extracellular volume (ECV) by CMR.
Outcome measures
| Measure |
Normal Participants
n=13 Participants
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
|
Hypertensive Participants
n=12 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
|
HFpEF Patients
n=6 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
|
|---|---|---|---|
|
Extracellular Volume (ECV) by CMR in Each Study Group
|
31.9 percent ECV
Interval 28.5 to 34.2
|
29.2 percent ECV
Interval 27.4 to 33.1
|
30.9 percent ECV
Interval 29.4 to 32.8
|
SECONDARY outcome
Timeframe: Baseline study visitPopulation: Incomplete data for 4 because of either inability to complete scan OR scan quality not adequate for analysis.
Oxidative metabolism (Kmono/rate pressure product) by PET.
Outcome measures
| Measure |
Normal Participants
n=16 Participants
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
|
Hypertensive Participants
n=14 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
|
HFpEF Patients
n=6 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
|
|---|---|---|---|
|
Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.
|
0.12 min-1/(beats/min x mmhg)
Interval 0.1 to 0.13
|
0.09 min-1/(beats/min x mmhg)
Interval 0.07 to 0.11
|
0.09 min-1/(beats/min x mmhg)
Interval 0.09 to 0.1
|
SECONDARY outcome
Timeframe: Baseline study visitPopulation: We were able to collect data on all participants who completed the study.
E/e' by echo. E is the transmitral peak velocity in early diastole. e' is the early diastolic tissue Doppler velocity average between the septal and lateral mitral annulus. E/e' is the ratio of these two values.
Outcome measures
| Measure |
Normal Participants
n=17 Participants
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
|
Hypertensive Participants
n=15 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
|
HFpEF Patients
n=8 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
|
|---|---|---|---|
|
E/e' by Echo in Each Study Group.
|
7.2 ratio
Interval 6.4 to 9.0
|
8.2 ratio
Interval 7.2 to 9.4
|
13.0 ratio
Interval 10.2 to 18.9
|
Adverse Events
Normal Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypertensive Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HFpEF Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marvin Kronenberg, MD
Vanderbilt University Medical Center
Phone: 615-322-2318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place