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NCT Number: NCT06578234

Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital

Lund, Sweden

Location status: Recruiting

Location contact

Henrik Engblom, Professor, MD

CONTACT

046171000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

Patients:

  • Acute referral (in-house patients)
  • Clinically unstable
  • Acute chest pain
  • Severe or decompensated heart failure
  • Non sinus rhythm (e.g. atrial fibrillation)
  • 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

Treatment and study plan

Adenosine

Drug

Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine

Primary outcomes

  1. 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).

Secondary outcomes

  1. Heart rate response

    Time frame: During adenosine infusion, 4-6 minutes

    Compare heart rate (beat/min) at standard and high dose adenosine

  2. Blood pressure response

    Time frame: During adenosine infusion, 4-6 minutes

    Compare systolic blood pressure (mmHg) at standard and high dose adenosine

  3. Symptoms

    Time frame: During adenosine infusion, 4-6 minutes

    Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine

Other outcomes

  1. Sex

    Time frame: In questionnaire obtained approximately 30 minutes before CMR examination

    The association between sex (female and male) and adenosine response

  2. Age

    Time frame: In questionnaire obtained approximately 30 minutes before CMR examination

    The association between age (years) and adenosine response

  3. Ejection fraction

    Time frame: Measured in the obtained short-axis cine images within approximately 6 months after acquisition

    The association between ejection fraction (%) assessed from CMR images and adenosine response

  4. Serum-caffeine

    Time frame: Blood samples are analysed within 9 months

    The association between serum caffeine levels (mg/L) assessed from blood samples and adenosine response

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Engblom, MD, PhD

CONTACT

[email protected]

046171000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: HYPER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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