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Status unknownNCT03235700HF-FFRUpdated Aug 1, 2017

Hyperemic Efficacy of IV Adenosine in HFrEF

An interventional study of Maximal hyperemia with adenosine followed by nicorandil and Maximal hyperemia with nicorandil followed by adenosine in Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, sponsored by Sejong General Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Sejong General Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction
  • Coronary Artery Disease

Keywords

  • heart failure with reduced ejection fraction
  • intermediate coronary stenosis
  • adenosine
  • hyperemia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • angiographically proven epicardial intermediate stenosis (40-70%)
  • echocardiographically proven LV dysfunction (LVEF ≤40%)

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    Adenosine followed by nicorandil

    Other: Maximal hyperemia with adenosine followed by nicorandil

  • Experimental
    Nicorandil followed by adenosine

    Other: Maximal hyperemia with nicorandil followed by adenosine

Interventions

  • OtherMaximal hyperemia with adenosine followed by nicorandil

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

  • OtherMaximal hyperemia with nicorandil followed by adenosine

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

05

What researchers measure

Primary outcomes

  1. Failure to induce maximal hyperemia

    no hyperemia, cyclic hyperemia, and submaximal hyperemia

    Time frame: less than 1 day

Secondary outcomes

  1. Fractional flow reserve

    Time frame: less than 1 day

  2. time to maximal hyperemia

    Time frame: less than 1 day

06

Study locations

1 of 1 sites recruiting
  • Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
    Bucheon, Gyeonggi 422-711, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03235700
Lead sponsor
Sejong General Hospital
Responsible party
Sponsor
First posted
Aug 1, 2017
Start date
Mar 1, 2017
Primary completion
Feb 28, 2020 (estimated)
Completion
Feb 28, 2020 (estimated)
Last update
Aug 1, 2017

Study contacts

Ho-Jun Jang, MD
Contact
hojunjang77@gmail.com
+82-32-340-1445

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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