Heart Failure With Reduced Ejection FractionHF-FFRNCT03235700
Hyperemic Efficacy of IV Adenosine in HFrEF
A study testing Maximal hyperemia with adenosine followed by nicorandil and Maximal hyperemia with nicorandil followed by adenosine in people with Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by Sejong General Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
- What is being tested?
- Maximal hyperemia with adenosine followed by nicorandil and Maximal hyperemia with nicorandil followed by adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- angiographically proven epicardial intermediate stenosis (40-70%)
- echocardiographically proven LV dysfunction (LVEF ≤40%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 422-711
Hyun-Jong Lee, MD, 82-10-6217-9315, untouchables@sejongh.co.kr
About this study
Official title: Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
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.
- Being tested
- Maximal hyperemia with adenosine followed by nicorandil, Maximal hyperemia with nicorandil followed by adenosine
- Keywords
- heart failure with reduced ejection fraction, intermediate coronary stenosis, adenosine, hyperemia
- Medical subject headings
- Coronary Artery Disease, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal hyperemia with adenosine followed by nicorandilOther
IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
Maximal hyperemia with nicorandil followed by adenosineOther
IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
| Study group | Role | What they receive |
|---|---|---|
| Adenosine followed by nicorandil | Experimental | Not described Receives: Other: Maximal hyperemia with adenosine followed by nicorandil |
| Nicorandil followed by adenosine | Experimental | Not described Receives: Other: Maximal hyperemia with nicorandil followed by adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to induce maximal hyperemia
no hyperemia, cyclic hyperemia, and submaximal hyperemia
Measured: less than 1 day
Secondary outcomes (2)
Fractional flow reserve
Measured: less than 1 day
time to maximal hyperemia
Measured: less than 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Mar 2017
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235700
- Sponsor's protocol ID
- 1642
- Acronym
- HF-FFR
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperemic Efficacy of Intravenous Infusion of Adenosine in Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03235700
- Acronym / sponsor ID
- HF-FFR / 1642
- Keywords
- heart failure with reduced ejection fraction, intermediate coronary stenosis, adenosine, hyperemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- angiographically proven epicardial intermediate stenosis (40-70%)
- echocardiographically proven LV dysfunction (LVEF ≤40%)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal hyperemia with adenosine followed by nicorandilIV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2 | Other | Adenosine followed by nicorandil |
| Maximal hyperemia with nicorandil followed by adenosineIC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) | Other | Nicorandil followed by adenosine |
Primary outcome
Failure to induce maximal hyperemia
Time frame: less than 1 day
no hyperemia, cyclic hyperemia, and submaximal hyperemia
2 secondary outcomes
Fractional flow reserve
Time frame: less than 1 day
time to maximal hyperemia
Time frame: less than 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal hyperemia with adenosine followed by nicorandil and Maximal hyperemia with nicorandil followed by adenosine in people with Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by Sejong General Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Jun Jang, MD (+82-32-340-1445, hojunjang77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure to induce maximal hyperemia (time frame: less than 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.