Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)

Stopped early · Phase 4

Conditions studied: Congestive Heart Failure

In brief

This pilot study will assess the impact of sacubitril/valsartan (trade name Entresto) on the elevated pulmonary artery pressures in patients with heart failure with reduced ejection fraction, measured using a previously implanted hemodynamic monitoring device (CardioMEMS).

Key facts

Study ID

NCT02788656

Run by

Brigham and Women's Hospital

People needed

4

Starts

2016-09-01

Expected to finish

2018-11-09

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients able to provide written informed consent
• Patients ≥18 years of age, male or female, in NYHA Class II- III HF, previously hospitalized for HFrEF with LVEF < 35% (measured within the past year), and who have no subsequent LVEF>35%.
• Systolic BP > 95 mm Hg at most recent clinical assessment.
• Stable, ambulatory patients without the need for change in diuretics and other HF drugs (RAS blockers, beta blockers or mineralocorticoid receptor blockers) during the past 5 days
• CardioMEMS HF System implanted for NYHA Class III HF. Patient transmitting information regularly and system functioning appropriately.
• NT-proBNP > 500 pg/ml within 90 days of CardioMEMS implantation.
• Average PAPm >20mm Hg during the 7 days prior to enrollment, including at least 4 daily measurements.
• Women of childbearing age must be on highly effective method of contraception

You may not qualify if…

• Treatment with vasodilators (other than nitrates, hydralazine) and/or IV inotropic drugs.
• Entresto taken within the past 30 days.
• History of hypersensitivity, intolerance or angioedema to previous renin-angiotensin system (RAS) blocker, ACE inhibitor, ARB, or Entresto.
• eGFR < 30 ml/min/1.73 m2 as measured by the simplified MDRD formula.
• Serum potassium > 5.5 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.
• Implantation of a cardiac resynchronization therapy device (CRT/D) within the pr preceding 3 months or intent to implant a CRT/D, which may alter the pressures during the course of the study.
• History of heart transplantation, placement of an LVAD, listing for Status IA for cardiac transplantation or planned placement of an LVAD within 3 months following randomization.
• 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
• Chronic lithium use

Where it is running

• Brigham and Women's Hospita — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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