Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD

• Status: Withdrawn
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (Entresto) versus usual anti-hypertensive medications in patients with left ventricular assist devices (LVAD). It also measures diurnal blood pressure variations in the context of continuous flow physiology.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, College Park
• Collaborator: Medtronic
• Treatments: Antihypertensive Agents; LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

• More than 30 days after LVAD implant

• Ambulatory

• MAP > 85 mmHg requiring initiation of anti-hypertensive medications

Exclusion Criteria:

• Allergy to ACEI or ARB

• eGFR < 30 mL/min/1.73m2

• K > 5.4 mmol/L

• MAP < 60

• Inability to check blood pressure at home

• Lack of prescription coverage

• Frequent hospitalizations (monthly)