Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
Condition: Heart Failure, Diastolic; Diastolic Heart Failure; Hypertension
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: regadenoson
Intervention description: evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: magnetic resonance imaging; positron-emission tomography; echocardiography; myocardial blood flow; energy metabolism

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.
    

Eligibility criteria:

        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