Chronic Coronary SyndromePhase 4HYPERNCT06578234
Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
A Phase 4 study testing Adenosine in people with Chronic Coronary Syndrome and Coronary Artery Disease, run by Region Skane at 1 site in Sweden.
Trial summary
Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Coronary Syndrome, Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- Adenosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 23 Oct 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- The subject has given their written consent to participate in the trial.
- Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
- Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to >80 years old)
- Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
- No caffein intake <24h prior to the examination
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- Healthy volunteers:
- The subject has given their written consent to participate in the trial.
- Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to >80 years old)
- No caffein intake <24h prior to the examination
Who cannot join
- Patients:
- Acute referral (in-house patients)
- Clinically unstable
- Acute chest pain
- Severe or decompensated heart failure
- Non sinus rhythm (e.g. atrial fibrillation)
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- Asthma or severe chronic obstructive pulmonary disease
- Known chronic renal failure (eGFR <45mL/min/1.73m2)
- AV-block II or III
- Left Bundle Branch Block
- Systolic blood pressure <90 mmHg or >230 mmHg at rest
- Increased intracranial pressure
- Known allergy or adverse reaction to adenosine or mannitol
- Known allergy or adverse reaction to gadolinium contrast agents
- Treatment with medication containing dipyradimol or teofyllamin/teofyllin
- Claustrophobia
- Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)
- Pregnancy or breast feeding (screened by question only)
- Inability to give informed consent due to mental state, language difficulties etc
- Healthy volunteers:
- Any of the exclusion criteria for patients
- Blood pressure > 140/90 measured according to clinical routine
- Known systemic disease
- Known cardiac disease
- Cardiovascular medication
- Medication that might influence cardiovascular health
- Smoking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital
Lund
Henrik Engblom, Professor, MD, 046171000
About this study
Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.
- Being tested
- Adenosine
- Keywords
- Myocardial perfusion, Cardiac Magnetic Resonance, Adenosine
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine
| Study group | Role | What they receive |
|---|---|---|
| Start standard dose adenosine followed by high dose adenosine | Active comparator | Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 140 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 210 μg/kg/min adenosine. Receives: Drug: Adenosine |
| Start high dose adenosine followed by standard dose adenosine | Active comparator | Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 210 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 140 μg/kg/min adenosine. Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial hyperemia
The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).
Measured: During adenosine infusion, 4-6 minutes
Secondary outcomes (3)
Heart rate response
Compare heart rate (beat/min) at standard and high dose adenosine
Measured: During adenosine infusion, 4-6 minutes
Blood pressure response
Compare systolic blood pressure (mmHg) at standard and high dose adenosine
Measured: During adenosine infusion, 4-6 minutes
Symptoms
Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine
Measured: During adenosine infusion, 4-6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start23 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The subjects will be randomized to start with one of the two adenosine doses, followed by the other dose 10 minutes later during the same examination.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578234
- Sponsor's protocol ID
- 2023-505248-20-00
- Other IDs
- 2023
- Acronym
- HYPER
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
- ClinicalTrials.gov ID
- NCT06578234
- Acronym / sponsor ID
- HYPER / 2023-505248-20-00
- Keywords
- Myocardial perfusion, Cardiac Magnetic Resonance, Adenosine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The subjects will be randomized to start with one of the two adenosine doses, followed by the other dose 10 minutes later during the same examination.
| Arm | Type | Receives |
|---|---|---|
| Start standard dose adenosine followed by high dose adenosine | Active comparator | Drug: AdenosineSubjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 140 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 210 μg/kg/min adenosine. |
| Start high dose adenosine followed by standard dose adenosine | Active comparator | Drug: AdenosineSubjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 210 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 140 μg/kg/min adenosine. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject has given their written consent to participate in the trial.
- Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
- Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to >80 years old)
- Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
- No caffein intake <24h prior to the examination
Key exclusion criteria (27 listed)
- Acute referral (in-house patients)
- Clinically unstable
- Acute chest pain
- Severe or decompensated heart failure
- Non sinus rhythm (e.g. atrial fibrillation)
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 |
|---|---|---|
| AdenosineStandard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine | Drug | Start high dose adenosine followed by standard dose adenosine, Start standard dose adenosine followed by high dose adenosine |
Primary outcome
Myocardial hyperemia
Time frame: During adenosine infusion, 4-6 minutes
The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).
3 secondary outcomes
Heart rate response
Time frame: During adenosine infusion, 4-6 minutes
Blood pressure response
Time frame: During adenosine infusion, 4-6 minutes
Symptoms
Time frame: During adenosine infusion, 4-6 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adenosine in people with Chronic Coronary Syndrome and Coronary Artery Disease, run by Region Skane at 1 site in Sweden.
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 10 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik Engblom, MD, PhD (046171000, henrik.engblom@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial hyperemia (time frame: During adenosine infusion, 4-6 minutes). 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 13 Aug 2026.