Phase 4
N=55
Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
Heart Failure, Diastolic · Diastolic Heart Failure · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02589977 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Coronary Flow Reserve — 2.64; 2.65; 2.06 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- regadenoson (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Marvin W. Kronenberg, M.D.
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coronary Flow Reserve |
2.64; 2.65; 2.06 | — |
| SECONDARY Myocardial Perfusion Reserve by CMR in Each Study Group. |
2.19; 1.74; 1.29 | — |
| SECONDARY Extracellular Volume (ECV) by CMR in Each Study Group |
31.9; 29.2; 30.9 | — |
| SECONDARY Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group. |
0.12; 0.09; 0.09 | — |
| SECONDARY E/e' by Echo in Each Study Group. |
7.2; 8.2; 13.0 | — |
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
- 1 or more antihypertensive medications
- LV ejection fraction (LVEF) at least 50%
- current BP 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
Data sourced from ClinicalTrials.gov (NCT02589977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.