HYPER-trial Hyperemic mYocardial Perfusion by adEnosine at diffeRent doses
EU CTIS ID: 2023-505248-20-00
What this study is testing
The primary objective of this trial is to investigate if the hyperemic response to adenosine differs significantly when using the standard dose of adenosine (140 μg/kg/min) versus high dose of adenosine (210 μg/kg/min) depending on if the subject is a) Healthy b) Patient with suspected/known CCS and no previously known heart failure c) Patient with suspected/known CCS and known heart failure
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- To be included in the trial, the patients must meet all of the following criteria: 1) The subject has given their written consent to participate in the trial. 2) Are referred to Department of Clinical Physiology, Lund University, for suspected or known CCS or heart failure 3) 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) 4) Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c) 5) No caffein intake <24h prior to the examination To be included in the trial, the healthy subjects must meet all of the following criteria: 1) The subject has given their written consent to participate in the trial. 2) 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) 3) No caffein intake <24h prior to the examination
You likely can't join if
- Patients must not be included in this trial if any of the following criteria are met: 1) Acute referral (in-house patients) 2) Clinically unstable 3) Acute chest pain 4) Severe or decompensated heart failure 5) Non sinus rhythm (e.g. atrial fibrillation) 6) Asthma or severe chronic obstructive pulmonary disease 7) Known chronic renal failure (eGFR <30mL/min/1.73m2) 8) AV-block II or III 9) Left Bundle Branch Block 10) Systolic blood pressure <90 mmHg or >230 mmHg at rest 11) Increased intracranial pressure 12) Known allergy or adverse reaction to adenosine or mannitol 13) Known allergy or adverse reaction to gadolinium contrast agents 14) Treatment with medication containing dipyradimol or teofyllamin/teofyllin 15) Claustrophobia 16) Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc) 17) Pregnancy or breast feeding (screened by question only) 18) Inability to give informed consent due to mental state, language difficulties etc Healthy subjects must not be included in this trial if any of the exclusion criteria for patients are met or any of the following criteria are met: 1) Blood pressure > 140/90 measured according to clinical routine 2) Known systemic disease 3) Known cardiac disease 4) Cardiovascular medication 5) Medication that might influence cardiovascular health 6) Smoking
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.