Hyperemic Efficacy of IV Adenosine in HFrEF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction

Conditions
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Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease

Intervention / Treatment
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* Other: Maximal hyperemia with adenosine followed by nicorandil
* Other: Maximal hyperemia with nicorandil followed by adenosine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenosine followed by nicorandil<br> | Other: Maximal hyperemia with adenosine followed by nicorandil<br>* IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2<br>|
| Experimental: Nicorandil followed by adenosine<br> | Other: Maximal hyperemia with nicorandil followed by adenosine<br>* IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure to induce maximal hyperemia | no hyperemia, cyclic hyperemia, and submaximal hyperemia | less than 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional flow reserve |  | less than 1 day | 
| time to maximal hyperemia |  | less than 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermediate coronary stenosis, heart failure with reduced ejection fraction, adenosine, hyperemia