Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 1176 for:    adenosine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235700
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Sejong General Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Coronary Artery Disease Other: Maximal hyperemia with adenosine followed by nicorandil Other: Maximal hyperemia with nicorandil followed by adenosine Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Adenosine

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)




Primary Outcome Measures :
  1. Failure to induce maximal hyperemia [ Time Frame: less than 1 day ]
    no hyperemia, cyclic hyperemia, and submaximal hyperemia


Secondary Outcome Measures :
  1. Fractional flow reserve [ Time Frame: less than 1 day ]
  2. time to maximal hyperemia [ Time Frame: less than 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235700


Contacts
Layout table for location contacts
Contact: Ho-Jun Jang, MD +82-32-340-1445 hojunjang77@gmail.com

Locations
Layout table for location information
Korea, Republic of
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu Recruiting
Bucheon, Gyeonggi, Korea, Republic of, 422-711
Contact: Hyun-Jong Lee, MD    82-10-6217-9315    untouchables@sejongh.co.kr   
Sponsors and Collaborators
Sejong General Hospital

Layout table for additonal information
Responsible Party: Sejong General Hospital
ClinicalTrials.gov Identifier: NCT03235700     History of Changes
Other Study ID Numbers: 1642
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sejong General Hospital:
heart failure with reduced ejection fraction
intermediate coronary stenosis
adenosine
hyperemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenosine
Heart Failure
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nicorandil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances