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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT04753112
Eligibility Criteria:
Inclusion Criteria:
* Patients able to provide written informed consent.
* Patients ≥18 years of age, male or female, in NYHA Class II- III HFpEF with LVEF \> 45% (measured within the past year), and who have no previous LVEF\<45%.
* NT-proBNP \>200 pg/ml if HF hospitalization in the previous 9 months and\> 300 pg/ml if there was no previous HF hospitalization; Three times the values were required in patients with atrial fibrillation.
* CardioMEMS HF System implanted and patient transmitting information regularly and system functioning appropriately.
* Average PAPm \>20mm Hg during the 7 days prior to enrollment, including at least 5 daily measurements.
* Systolic BP \> 100 mm Hg at most recent clinical assessment.
* Stable, ambulatory patients without the need for change in diuretics and other HF drugs during last week.
Exclusion Criteria:
* eGFR \< 30 ml/min/1.73 m2 as measured by CKD-EPI.
* Sacubitril/Valsartan treatment within the past 30 days.
* History of hypersensitivity, intolerance or angioedema to previous renin-angiotensin system (RAS) blocker, ACE inhibitor, ARB, or Entresto.
* Serum potassium \> 5.4 mmol/L.
* Acute coronary syndrome, stroke, transient ischemic attack, cardiovascular surgery, PCI, or carotid angioplasty within the preceding 3 months.
* Coronary or carotid artery disease likely to require surgical or percutaneous intervention within 3 months after trial entry.
* Non-cardiac condition(s) as the primary cause of dyspnea.
* Documented untreated ventricular arrhythmia with syncopal episodes within the prior 3 months.
* Symptomatic bradycardia or second or third degree heart block without a pacemaker.
* Hepatic dysfunction, as evidenced by total bilirubin \> 3 mg/dl.
* Pregnancy.
* Women who are breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04753112
Study Brief:
Protocol Section:
NCT04753112