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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT02874794
Eligibility Criteria:
Inclusion Criteria:
* History of HTN and one of the following at BOTH screening and pre-randomization:
1. SBP \>105 mm Hg on antihypertensive medication.
2. SBP \>/= 140 mm Hg and NOT on antihypertensive medication.
* NYHA class I-III heart failure and with reduced ejection fraction \</= 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met.
* On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization.
1. If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2).
2. If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required.
* On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease.
Key Exclusion Criteria:
* History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
* Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration.
* History of angioedema, drug-related or otherwise.
* Requirement of treatment with both ACE inhibitor and ARB.
* Current or prior treatment with sacubitril and valsartan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02874794
Study Brief:
Protocol Section:
NCT02874794