A Phase 4 interventional study of regadenoson in Heart Failure, Diastolic, Diastolic Heart Failure and Hypertension, sponsored by Marvin W. Kronenberg, M.D.. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Marvin W. Kronenberg, M.D. · Phase 4, Interventional, and Diagnostic
Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and devices have been demonstrated to reduce mortality, no such therapies have been identified in HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms of HFpEF.
Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and increased myocardial fibrosis have been postulated to play important pathophysiologic roles in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with altered myocardial energy utilization and "energy starvation." However, there are limited data regarding "energy starvation" in HFpEF and the relationships between myocardial blood flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes of this study are to use non-invasive cardiac imaging techniques to describe cardiac structure, function, blood flow, energetics, and fibrosis, and the relationships between these in order to better understand underlying mechanisms in HFpEF.
The investigators hypothesize that HFpEF is associated with reductions in myocardial blood flow and energy utilization and increased myocardial fibrosis as compared to age and gender matched hypertensive and healthy controls. The investigators will test their hypotheses by comparing measurements of myocardial blood flow, energy utilization, and fibrosis between three subject groups (HFpEF vs hypertension vs healthy). Myocardial blood flow will be quantitated from nitrogen (N)13-Ammonia positron emission tomography (PET) and gadolinium enhanced cardiac magnetic resonance (CMR) imaging, both at rest and stress following coronary vasodilation with regadenoson. Myocardial energy utilization will be quantified with 11C-acetate PET imaging and myocardial fibrosis will be assessed with gadolinium enhanced CMR and alterations in myocardial T1. Echocardiography will be utilized to quantify cardiac diastolic function.
It is anticipated that the results of this proposed study will provide a foundation that will inform future studies aimed at identifying novel preventive or therapeutic agents in HFpEF.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 55 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Marvin W. Kronenberg, M.D. as lead sponsor.
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Inclusion Criteria:
Exclusion Criteria:
HEALTHY
Inclusion criteria:
Exclusion criteria:
HYPERTENSIVE
Inclusion criteria:
Exclusion criteria:
HFpEF
Inclusion criteria:
Exclusion criteria:
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.
Drug: regadenoson
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.
Drug: regadenoson
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.
Drug: regadenoson
evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
Also known as: positron emission tomography, echocardiography, cardiac magnetic resonance imaging
Coronary Flow Reserve
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
Myocardial Perfusion Reserve by CMR in Each Study Group.
Myocardial perfusion reserve by CMR.
Time frame: Baseline study visit.
Extracellular Volume (ECV) by CMR in Each Study Group
Extracellular volume (ECV) by CMR.
Time frame: Baseline study visit
Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.
Oxidative metabolism (Kmono/rate pressure product) by PET.
Time frame: Baseline study visit
E/e' by Echo in Each Study Group.
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
| Milestone | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| Started | 23 | 20 | 12 |
| Completed | 17 | 15 | 8 |
| Not completed | 6 | 5 | 4 |
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.
| ratio | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| Coronary Flow Reserve | 2.64 (2.34 to 2.85) | 2.65 (2.56 to 3.11) | 2.06 (1.96 to 2.26) |
Myocardial perfusion reserve by CMR.
| ratio | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| Myocardial Perfusion Reserve by CMR in Each Study Group. | 2.19 (1.81 to 2.64) | 1.74 (1.44 to 2.59) | 1.29 (1.11 to 1.32) |
Extracellular volume (ECV) by CMR.
| percent ECV | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| Extracellular Volume (ECV) by CMR in Each Study Group | 31.9 (28.5 to 34.2) | 29.2 (27.4 to 33.1) | 30.9 (29.4 to 32.8) |
Oxidative metabolism (Kmono/rate pressure product) by PET.
| min-1/(beats/min x mmhg) | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group. | 0.12 (0.10 to 0.13) | 0.09 (0.07 to 0.11) | 0.09 (0.09 to 0.10) |
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.
| ratio | Normal Participants | Hypertensive Participants | HFpEF Patients |
|---|---|---|---|
| E/e' by Echo in Each Study Group. | 7.2 (6.4 to 9.0) | 8.2 (7.2 to 9.4) | 13.0 (10.2 to 18.9) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Participants | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Hypertensive Participants | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| HFpEF Patients | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
These are the people who attended baseline visit.
| Age, Continuous(years) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| Median | 57 (54 to 62) | 58 (54 to 65) | 69 (62 to 73) | 58 (55 to 67) |
| Sex: Female, Male(Participants) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| Female | 12 | 5 | 7 | 24 |
| Male | 5 | 10 | 1 | 16 |
| Race (NIH/OMB)(Participants) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 16 | 15 | 7 | 38 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| United States | 17 | 15 | 8 | 40 |
| Hypertension(Participants) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| Count of participants | 0 | 15 | 8 | 23 |
| Diabetes(Participants) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| Count of participants | 0 | 0 | 3 | 3 |
| BMI(kg/m^2) | Normal Participants | Hypertensive Participants | HFpEF Patients | Total |
|---|---|---|---|---|
| Median | 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) |
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