Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
heart failure with reduced ejection fraction, intermediate coronary stenosis, adenosine, hyperemia
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.
Interventions
IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
Sponsors
Sejong General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure to induce maximal hyperemia | less than 1 day | no hyperemia, cyclic hyperemia, and submaximal hyperemia |
Secondary
| Measure | Time frame |
|---|---|
| Fractional flow reserve | less than 1 day |
| time to maximal hyperemia | less than 1 day |
Countries
South Korea
Contacts
Primary ContactHo-Jun Jang, MD
Outcome results
None listed