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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235700
Recruitment Status : Unknown
Verified July 2017 by Sejong General Hospital.
Recruitment status was:  Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Sejong General Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 1, 2017
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)		 Failure to induce maximal hyperemia [ Time Frame: less than 1 day ]
no hyperemia, cyclic hyperemia, and submaximal hyperemia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Fractional flow reserve [ Time Frame: less than 1 day ]
  • time to maximal hyperemia [ Time Frame: less than 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperemic Efficacy of IV Adenosine in HFrEF
Official Title  ICMJE Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Heart Failure With Reduced Ejection Fraction
  • Coronary Artery Disease
Intervention  ICMJE
  • Other: Maximal hyperemia with adenosine followed by nicorandil
    IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
  • Other: Maximal hyperemia with nicorandil followed by adenosine
    IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
Study Arms  ICMJE
  • Experimental: Adenosine followed by nicorandil
    Intervention: Other: Maximal hyperemia with adenosine followed by nicorandil
  • Experimental: Nicorandil followed by adenosine
    Intervention: Other: Maximal hyperemia with nicorandil followed by adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2017)		 125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03235700
Other Study ID Numbers  ICMJE 1642
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sejong General Hospital
Study Sponsor  ICMJE Sejong General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sejong General Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP