HYPER-trial Hyperemic mYocardial Perfusion by adEnosine at diffeRent doses

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

14 Oct 2024 → ongoing

Decision date (initial)

2024-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Hjärt-lungfonden · ALF

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Diagnosis

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

Conditions and MedDRA coding

Chronic coronary syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint, myocardial hyperemia, is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Henrik Engblom

Public contact point

Organisation

Region Skane

Contact name

Henrik Engblom

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications