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

July 28, 2017 updated by: Sejong General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Bucheon, Gyeonggi, Korea, Republic of, 422-711
        • Recruiting
        • Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Fractional flow reserve
Time Frame: less than 1 day
less than 1 day
time to maximal hyperemia
Time Frame: less than 1 day
less than 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sejong General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

February 28, 2020

Study Completion (ANTICIPATED)

February 28, 2020

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (ACTUAL)

August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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