Hyperemic Efficacy of IV Adenosine in HFrEF

Not Applicable

• Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Maximal hyperemia with nicorandil followed by adenosine; Other: Maximal hyperemia with adenosine followed by nicorandil

• Registration Number: NCT03235700
• Lead Sponsor: Sejong General Hospital

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 Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-28
• Study First Posted: 2017-08-01
• Last Update Posted: 2017-08-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicorandil followed by adenosine	Maximal hyperemia with nicorandil followed by adenosine	-
Adenosine followed by nicorandil	Maximal hyperemia with adenosine followed by nicorandil	-

Primary Outcome Measures

Name	Time	Method
Failure to induce maximal hyperemia	less than 1 day	no hyperemia, cyclic hyperemia, and submaximal hyperemia

Secondary Outcome Measures

Name	Time	Method
Fractional flow reserve	less than 1 day
time to maximal hyperemia	less than 1 day

Trial Locations

Locations (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of