Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 2/24/2019 |
| Start Date: | November 2015 |
| End Date: | August 2020 |
| Contact: | Marvin W Kronenberg, MD |
| Email: | marvin.w.kronenberg@vanderbilt.edu |
| Phone: | 615-322-8822 |
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Marvin Kronenberg, MD
Phone: 615-322-8822
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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