Hyperemic Efficacy of IV Adenosine in HFrEF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-02-28

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.

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adenosine followed by nicorandil

Group Type EXPERIMENTAL

Maximal hyperemia with adenosine followed by nicorandil

Intervention Type OTHER

IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2

Nicorandil followed by adenosine

Group Type EXPERIMENTAL

Maximal hyperemia with nicorandil followed by adenosine

Intervention Type OTHER

IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)

Interventions

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Maximal hyperemia with adenosine followed by nicorandil

IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2

Intervention Type OTHER

Maximal hyperemia with nicorandil followed by adenosine

IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No