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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
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Marvin W. Kronenberg, M.D., Vanderbilt University Medical Center

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
These are the people who attended baseline visit.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 8 participants 40 participants
57
(54 to 62)
58
(54 to 65)
69
(62 to 73)
58
(55 to 67)
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%
5
  33.3%
7
  87.5%
24
  60.0%
Male
5
  29.4%
10
  66.7%
1
  12.5%
16
  40.0%
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%
0
   0.0%
0
   0.0%
0
   0.0%
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%
38
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
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%
8
 100.0%
23
  57.5%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 8 participants 40 participants
0
   0.0%
0
   0.0%
3
  37.5%
3
   7.5%
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)
30.1
(27.8 to 35.7)
34.2
(29.9 to 37.8)
29.7
(25.6 to 33.0)
1.Primary Outcome
Title Coronary Flow Reserve
Hide Description 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.
Time Frame Baseline study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Incomplete data for 18 because of either inability to complete scan OR scan quality not adequate for analysis.
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 10 6 6
Median (Inter-Quartile Range)
Unit of Measure: ratio
2.64
(2.34 to 2.85)
2.65
(2.56 to 3.11)
2.06
(1.96 to 2.26)
2.Secondary Outcome
Title Myocardial Perfusion Reserve by CMR in Each Study Group.
Hide Description Myocardial perfusion reserve by CMR.
Time Frame Baseline study visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Incomplete data for 10 because of either inability to complete scan OR scan quality not adequate for analysis.
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 15 12 3
Median (Inter-Quartile Range)
Unit of Measure: ratio
2.19
(1.81 to 2.64)
1.74
(1.44 to 2.59)
1.29
(1.11 to 1.32)
3.Secondary Outcome
Title Extracellular Volume (ECV) by CMR in Each Study Group
Hide Description Extracellular volume (ECV) by CMR.
Time Frame Baseline study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Incomplete data for 9 because of either inability to complete scan OR scan quality not adequate for analysis.
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 13 12 6
Median (Inter-Quartile Range)
Unit of Measure: percent ECV
31.9
(28.5 to 34.2)
29.2
(27.4 to 33.1)
30.9
(29.4 to 32.8)
4.Secondary Outcome
Title Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.
Hide Description Oxidative metabolism (Kmono/rate pressure product) by PET.
Time Frame Baseline study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Incomplete data for 4 because of either inability to complete scan OR scan quality not adequate for analysis.
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 16 14 6
Median (Inter-Quartile Range)
Unit of Measure: min-1/(beats/min x mmhg)
0.12
(0.10 to 0.13)
0.09
(0.07 to 0.11)
0.09
(0.09 to 0.10)
5.Secondary Outcome
Title E/e' by Echo in Each Study Group.
Hide Description 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.
Time Frame Baseline study visit
Hide Outcome Measure Data
Hide Analysis Population Description
We were able to collect data on all participants who completed the study.
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 17 15 8
Median (Inter-Quartile Range)
Unit of Measure: ratio
7.2
(6.4 to 9.0)
8.2
(7.2 to 9.4)
13.0
(10.2 to 18.9)
Time Frame This is a cross sectional study. Subjects were followed for adverse events between screening/enrollment to one day following completion of the cardiac imaging study visit. Because this was not a longitudinal study with serial measurements of the end points the time between enrollment and cross sectional cardiac imaging study visit was variable for each subject in accordance with the study protocol. All subjects completed study procedures within thirteen months of enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Participants Hypertensive Participants HFpEF Patients
Hide Arm/Group Description

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

All-Cause Mortality
Normal Participants Hypertensive Participants HFpEF Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/20 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Normal Participants Hypertensive Participants HFpEF Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/20 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Participants Hypertensive Participants HFpEF Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/20 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marvin Kronenberg, MD
Organization: Vanderbilt University Medical Center
Phone: 615-322-2318
EMail: marvin.w.kronenberg@vumc.org
Layout table for additonal information
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