Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE-HF)

About this Study

The purpose of this research study is to find out if the study drug, sacubitril/valsartan, is safe and has beneficial effects when added to conventional heart failure therapy in patients with heart failure with preserved ejection fraction who have been stabilized after being admitted to the hospital for new or worsening heart failure.

Sponsor Protocol ID:CLCZ696DUS01
IRB Number:2020-2778
Actively Enrolling
Phase 3
January 12, 2022
Eligibility Criteria
40 years old
Both Male and Female

Inclusion Criteria
  • Patient must be greater than or equal to 40 years of age, male or female
  • Currently in the hospital for OR within 30 days following discharge of an acute decompensated heart failure with preserved ejection fraction admission.  Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload
  • Heart failure with preserved ejection fraction with most recent left ventricular ejection fraction (LVEF) greater than 40% (within the past 3 months)
  • Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP) at the time of screening 
  • Han not taken an angiotensin converting enzyme inhibitor (ACEi) for 36 hours prior to randomization

Exclusion Criteria
  • Any problem within the 90 days prior to randomization that could have lowered left ventricular ejection fraction
  • Currently taking Entresto (sacubitril/valsartan) or any prior use
  • eGFR less than 20ml/min/1.73 
  • Serum potassium greater than 5.2 mEq/L at most recent assessment
  • Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major cardiovascular surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to randomization
  • Possibly a different diagnosis that in the opinion of the investigator could account for patient’s heart failure symptoms
  • Isolated right heart failure in the absence of left-sided structural heart disease
  • History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs including angiotensin receptor neprilysin inhibitor (i.e. sacubitril/valsartan), and/or angiotensin receptor neprilysin blocker (ARBs)
  • Patients with a known history of angioedema
  • Patients with a history of heart transplant or left ventricular access device (LVAD), currently on the transplant list, or with planned intent to implant LVAD or (cardiac resynchronization therapy (CRT) device within the initial three months of enrollment during the trial
  • A cardiac or non-cardiac medical condition other than heart failure with an estimated life expectancy of less than 12 months
  • Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
  • Life-threatening or uncontrolled irregular heart beats
  • Clinically significant congenital heart disease felt to be the cause of the patient’s symptoms and signs of heart failure
  • Coronary or carotid artery disease or valvular heart disease that will likely need surgical while on the trial
  • Known liver problems or history of cirrhosis with evidence of portal hypertension 
  • Participation in any other clinical trial involving investigational agents or devices within the past 30 days
  • Pregnant or nursing women