Hyperemic Efficacy of IV Adenosine in HFrEF (HF-FFR)

Sejong General Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Treatments: Other: Maximal hyperemia with adenosine followed by nicorandil; Other: Maximal hyperemia with nicorandil followed by adenosine

Study type: Interventional

Funder types: Other

Identifiers

NCT03235700

1642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Adenosine followed by nicorandil

Experimental group

Treatment:

Other: Maximal hyperemia with adenosine followed by nicorandil

Nicorandil followed by adenosine

Experimental group

Treatment:

Other: Maximal hyperemia with nicorandil followed by adenosine