Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Failure to induce maximal hyperemia
Study Overview
Brief Summary
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire.
Detailed Description
Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment using a coronary pressure wire. Patients with an angiographically intermediate lesion (40-70% diameter stenosis) in a major epicardial coronary artery and with left ventricle ejection fraction ≤40% will be prospectively enrolled. FFR under the various hyperemic stimulation using IV adenosine 140 & 180, IC adenosine, and IC nicorandil will be measured sequentially.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •angiographically proven epicardial intermediate stenosis (40-70%)
- •echocardiographically proven LV dysfunction (LVEF ≤40%)
Exclusion Criteria
- •infarct-related artery, less than 2 weeks
- •Killip class 3 and 4
- •bronchial asthma
- •second degree or third degree AV block
- •any contraindications to adenosine
Arms & Interventions
Nicorandil followed by adenosine
Intervention: Maximal hyperemia with nicorandil followed by adenosine (Other)
Adenosine followed by nicorandil
Intervention: Maximal hyperemia with adenosine followed by nicorandil (Other)
Outcomes
Primary Outcomes
Failure to induce maximal hyperemia
Time Frame: less than 1 day
no hyperemia, cyclic hyperemia, and submaximal hyperemia
Secondary Outcomes
- Fractional flow reserve(less than 1 day)
- time to maximal hyperemia(less than 1 day)