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:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03401151
Eligibility Criteria:
Inclusion criteria:
* Signed informed consent
* 60-80 years old upon inclusion
* Chronic heart failure ≥ 45 days.
* Left ventricular ejection fraction ≤ 35%.
* NYHA III-IV
* Receiving medical management with optimal doses of betablockers, acetylcholinesterase (ACE)-inhibitors or angiotensin II receptor blockers (ARB), and mineral receptor antagonists (MRA) for at least 30 days if tolerated.
Exclusion criteria:
* Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"
* On-going mechanical circulatory support.
* Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
* Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance
* Condition, other than heart failure, requiring end-of-life care within \<6 months in time or where the risk of death within \<2 years is considered to be imminent.
* Participation in studies that resulted in departure from normal treatment routine or invasive investigations within \<6 months back in time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT03401151
Study Brief:
Protocol Section:
NCT03401151