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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT02807857
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent and accept study procedures and time schedule.
* Age ≥ 18 years.
* Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).
* Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.
Exclusion Criteria:
* Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.
* Cancer or other significant co-morbidities implying that the patient's condition is unstable.
* Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR \< 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
* Patients who are primarily managed and regularly followed-up by a cardiologist for their HF
* Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02807857
Study Brief:
Protocol Section:
NCT02807857