NCT03235700

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 28, 2017

Last Update Submit

July 28, 2017

Conditions

Heart Failure With Reduced Ejection FractionCoronary Artery Disease

Keywords

heart failure with reduced ejection fractionintermediate coronary stenosisadenosinehyperemia

Outcome Measures

Primary Outcomes (1)

  • Failure to induce maximal hyperemia

    no hyperemia, cyclic hyperemia, and submaximal hyperemia

    less than 1 day

Secondary Outcomes (2)

  • Fractional flow reserve

    less than 1 day

  • time to maximal hyperemia

    less than 1 day

Study Arms (2)

Adenosine followed by nicorandil

EXPERIMENTAL
Other: Maximal hyperemia with adenosine followed by nicorandil

Nicorandil followed by adenosine

EXPERIMENTAL
Other: Maximal hyperemia with nicorandil followed by adenosine

Interventions

Maximal hyperemia with adenosine followed by nicorandilOTHER

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

Adenosine followed by nicorandil
Maximal hyperemia with nicorandil followed by adenosineOTHER

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

Nicorandil followed by adenosine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu

Bucheon-si, Gyeonggi-do, 422-711, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseHyperemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Ho-Jun Jang, MD

CONTACT

+82-32-340-1445hojunjang77@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 1, 2017

Study Start

March 1, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

KR(1)