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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT04185103
Eligibility Criteria:
Inclusion Criteria:
* Adults from 18 to 80 years old.
* Patients with grade II heart failure according to the New York Heart Association (NYHA).
* Left systolic disfunction: left ventricle ejection fraction\<40%
* NT-proBNP \> 600 pg/ml (or \> 100 pg/ml in the case the patients has been hospitalised during the last year.
* Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study.
Exclusion Criteria:
* Previously treated with Sacubitril-Valsartan.
* Allergy or intolerance to ARA II.
* Systolic blood pressure \< 100 mmHG at inclusion.
* Glomerular Filtration \<35 ml / min / 1.73 m2 of body surface.
* Level of potassium \> 5,4 mEq/l.
* Impossibility to walk on a treadmill.
* Record of recovered sudden death or documented ventricular tachycardia.
* Carrier of an automatic implantable defibrillator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04185103
Study Brief:
Protocol Section:
NCT04185103