HFpEF-PRoF: Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF

• Sponsor: Marvin W. Kronenberg, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02589977
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 55
• Location: 1
• Arms: 3
• Duration (Months): 50.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic; Diastolic Heart Failure; Hypertension	Drug: regadenoson	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jan 21, 2020
• Actual Study Completion Date: Jan 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Drug: regadenoson; evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants; Other Names: positron emission tomography echocardiography cardiac magnetic resonance imaging
Other: 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.	Drug: regadenoson; evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants; Other Names: positron emission tomography echocardiography cardiac magnetic resonance imaging
Other: 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.	Drug: regadenoson; evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants; Other Names: positron emission tomography echocardiography cardiac magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

1. Coronary Flow Reserve [Baseline study visit]

   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.

Secondary Outcome Measures

1. Myocardial Perfusion Reserve by CMR in Each Study Group. [Baseline study visit.]

   Myocardial perfusion reserve by CMR.

2. Extracellular Volume (ECV) by CMR in Each Study Group [Baseline study visit]

   Extracellular volume (ECV) by CMR.

3. Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group. [Baseline study visit]

   Oxidative metabolism (Kmono/rate pressure product) by PET.

4. E/e' by Echo in Each Study Group. [Baseline study visit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

ALL

Inclusion Criteria:

• estimated glomerular filtration rate (eGFR) > 60 ml/min

• preserved left ventricular ejection fraction (>= 50%) on echocardiography

Exclusion Criteria:

• coronary artery disease

• diabetes mellitus

• contraindications to cardiac magnetic resonance imaging (CMR)

• weight >350 lbs

• inability to lie flat for imaging

• anemia

• contraindications to regadenoson or aminophylline

HEALTHY

Inclusion criteria:

• normal cardiac structure and function on echocardiography

• BP < 140/90

Exclusion criteria:

• known cardiovascular disease, cardiac risk factors or use of cardiac medications

HYPERTENSIVE

Inclusion criteria:

• history of BP >140/90

• 1 or more antihypertensive medications

• LV ejection fraction (LVEF) at least 50%

• current BP < 160/90

Exclusion criteria:

• known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications

HFpEF

Inclusion criteria:

• physician-confirmed diagnosis of HF

• symptomatic HF

• LVEF at least 50%

• elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100

• current BP < 160/90

Exclusion criteria:

• prior history of LVEF below 50%

• acute decompensated HF

• moderate or greater valvular disease

• significant cardiac arrhythmias

• pericardial disease

• congenital heart disease

• primary pulmonary hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Marvin W. Kronenberg, M.D.
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Marvin W Kronenberg, MD, Vanderbilt University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 10, 2019

More Information

Publications

None provided.

• Responsible Party: Marvin W. Kronenberg, M.D., Professor of Medicine and Radiology, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT02589977
• Other Study ID Numbers: 141686
• First Posted: Oct 28, 2015
• Last Update Posted: Feb 2, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Marvin W. Kronenberg, M.D., Professor of Medicine and Radiology, Vanderbilt University Medical Center: magnetic resonance imaging; positron-emission tomography; echocardiography; myocardial blood flow; energy metabolism
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Diastolic; Regadenoson

Study Results

Participant Flow

Arm/Group Title	Normal Participants	Hypertensive Participants	HFpEF Patients
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

Baseline Characteristics

Arm/Group Title	Normal Participants	Hypertensive Participants	HFpEF Patients	Total
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 Participants	17	15	8	40
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	57	58	69	58
Sex: Female, Male (Count of Participants)
Female	12 70.6%	5 33.3%	7 87.5%	24 60%
Male	5 29.4%	10 66.7%	1 12.5%	16 40%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 5.9%	0 0%	1 12.5%	2 5%
White	16 94.1%	15 100%	7 87.5%	38 95%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	15 100%	8 100%	40 100%
Hypertension (Count of Participants)
Count of Participants [Participants]	0 0%	15 100%	8 100%	23 57.5%
Diabetes (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	3 37.5%	3 7.5%
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	26.7	30.1	34.2	29.7

Outcome Measures

1. Primary Outcome

Title	Coronary Flow Reserve
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

Outcome Measure Data

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
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
Measure Participants	10	6	6
Median (Inter-Quartile Range) [ratio]	2.64	2.65	2.06

2. Secondary Outcome

Title	Myocardial Perfusion Reserve by CMR in Each Study Group.
Description	Myocardial perfusion reserve by CMR.
Time Frame	Baseline study visit.

Outcome Measure Data

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
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
Measure Participants	15	12	3
Median (Inter-Quartile Range) [ratio]	2.19	1.74	1.29

3. Secondary Outcome

Title	Extracellular Volume (ECV) by CMR in Each Study Group
Description	Extracellular volume (ECV) by CMR.
Time Frame	Baseline study visit

Outcome Measure Data

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
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
Measure Participants	13	12	6
Median (Inter-Quartile Range) [percent ECV]	31.9	29.2	30.9

4. Secondary Outcome

Title	Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.
Description	Oxidative metabolism (Kmono/rate pressure product) by PET.
Time Frame	Baseline study visit

Outcome Measure Data

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
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
Measure Participants	16	14	6
Median (Inter-Quartile Range) [min-1/(beats/min x mmhg)]	0.12	0.09	0.09

5. Secondary Outcome

Title	E/e' by Echo in Each Study Group.
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

Outcome Measure Data

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
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
Measure Participants	17	15	8
Median (Inter-Quartile Range) [ratio]	7.2	8.2	13.0

Adverse Events

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.
Arm/Group Title	Normal Participants		Hypertensive Participants		HFpEF Patients
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/12 (0%)
Serious Adverse Events
	Normal Participants		Hypertensive Participants		HFpEF Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Normal Participants		Hypertensive Participants		HFpEF Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.