Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05348460
Eligibility Criteria:
Inclusion Criteria:
* Chronic Heart Failure NYHA II - III
* LVEF ≤40%
* Stable for the last 1 month prior to the study
Exclusion Criteria:
* Age \<18 years;
* Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
* Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
* Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
* Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
* Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).
* BMI \< 16 kg/m2; BMI \> 35 kg/m2
* Unable to understand study procedures;
* Unable or unwilling to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05348460
Study Brief:
Protocol Section:
NCT05348460