Treatment of PH With Angiotensin II Receptor Blocker and Neprilysin Inhibitor in HFpEF Patients With CardioMEMS Device

• Status: Completed
• Trial end date: 2021-09-20
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the impact of sacubitril/valsartan on elevated pulmonary artery (PA) pressures in patients with heart failure (HF) with preserved ejection fraction (HFpEF), measured using a previously implanted hemodynamic monitoring device (CardioMEMS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

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