Back to resultsHyperemic Efficacy of IV Adenosine in HFrEF (HF-FFR)
Primary Purpose
Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Maximal hyperemia with adenosine followed by nicorandil
Maximal hyperemia with nicorandil followed by adenosine
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure With Reduced Ejection Fraction focused on measuring heart failure with reduced ejection fraction, intermediate coronary stenosis, adenosine, hyperemia
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
Sites / Locations
- Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-GuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adenosine followed by nicorandil
Nicorandil followed by adenosine
Arm Description
Outcomes
Primary Outcome Measures
Failure to induce maximal hyperemia
no hyperemia, cyclic hyperemia, and submaximal hyperemia
Secondary Outcome Measures
Fractional flow reserve
time to maximal hyperemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235700
Brief Title
Hyperemic Efficacy of IV Adenosine in HFrEF
Acronym
HF-FFR
Official Title
Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sejong General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
Keywords
heart failure with reduced ejection fraction, intermediate coronary stenosis, adenosine, hyperemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adenosine followed by nicorandil
Arm Type
Experimental
Arm Title
Nicorandil followed by adenosine
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Maximal hyperemia with adenosine followed by nicorandil
Intervention Description
IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
Intervention Type
Other
Intervention Name(s)
Maximal hyperemia with nicorandil followed by adenosine
Intervention Description
IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
Primary Outcome Measure Information:
Title
Failure to induce maximal hyperemia
Description
no hyperemia, cyclic hyperemia, and submaximal hyperemia
Time Frame
less than 1 day
Secondary Outcome Measure Information:
Title
Fractional flow reserve
Time Frame
less than 1 day
Title
time to maximal hyperemia
Time Frame
less than 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho-Jun Jang, MD
Phone
+82-32-340-1445
Email
hojunjang77@gmail.com
Facility Information:
Facility Name
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
City
Bucheon
State/Province
Gyeonggi
ZIP/Postal Code
422-711
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Jong Lee, MD
Phone
82-10-6217-9315
Email
untouchables@sejongh.co.kr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hyperemic Efficacy of IV Adenosine in HFrEF
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