Hyperemic Efficacy of IV Adenosine in HFrEF

Coronary Artery Disease Clinical Trial

— HF-FFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235700
• Other study ID #: 1642
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: March 1, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2017
• Source: Sejong General Hospital
• Contact: Ho-Jun Jang, MD
• Phone: +82-32-340-1445
• Email: hojunjang77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Myocardial Ischemia

Intervention

Other:
• Maximal hyperemia with adenosine followed by nicorandil
IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
• Maximal hyperemia with nicorandil followed by adenosine
IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)

Locations

Country	Name	City	State
Korea, Republic of	Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu	Bucheon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Sejong General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure to induce maximal hyperemia	no hyperemia, cyclic hyperemia, and submaximal hyperemia	less than 1 day
Secondary	Fractional flow reserve		less than 1 day
Secondary	time to maximal hyperemia		less than 1 day