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Clinical Trials/NCT03235700
NCT03235700
Unknown
Not Applicable

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

Sejong General Hospital1 site in 1 country125 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Reduced Ejection Fraction
Sponsor
Sejong General Hospital
Enrollment
125
Locations
1
Primary Endpoint
Failure to induce maximal hyperemia
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
February 28, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sejong General Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Failure to induce maximal hyperemia

Time Frame: less than 1 day

no hyperemia, cyclic hyperemia, and submaximal hyperemia

Secondary Outcomes

  • Fractional flow reserve(less than 1 day)
  • time to maximal hyperemia(less than 1 day)

Study Sites (1)

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