Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD

Hypertension Clinical Trial

Official title:

Sacubitril-valsartan (Entresto) Versus Standard Anti-hypertensive Therapy in LVAD Patients - A Feasibility Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03279861
• Other study ID #: HP-00076889
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 2017
• Est. completion date: November 2019

Study information

• Verified date: February 2018
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Left ventricular assist devices (LVAD) have become a life-saving therapy for patients with ACC/AHA stage D congestive heart failure (CHF). Despite longevity and improved quality of life, LVAD-supported patients are plagued with adverse events, the most debilitating of all is stroke. Ischemic and hemorrhagic strokes have been associated with hypertension (mean arterial pressure, or MAP > 90 mmHg) in addition to out-of-range INR and aspirin doses. Strict blood pressure control has been shown in a recent randomized trial to confer a significant decline in stroke rates of patients implanted with the Heartware LVAD. Patients with poorly controlled hypertension are also at risk for inadequate left-ventricular unloading and worsening CHF due to the exquisite sensitivity to afterload of the continuous flow LVAD. There are no guidelines for the use of anti-hypertensives in LVAD patients. Most are started on standard CHF therapies, though this practice varies greatly across LVAD centers. The angiotensin receptor blocker-neprilysin inhibitor sacubitril-valsartan (Entresto) is a potent anti-hypertensive mediation that was recently approved by the Food and Drug Administration for the treatment of patients with heart failure and low ejection fraction. We aim to randomly assign patients to receive Entresto or usual anti-hypertensive therapy for blood pressure control, then crossover to the other arm after 30 days. Daily blood pressure measurements will be performed and correlated with LVAD pump flows and waveform analysis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hypertension

Intervention

Drug:
• Entresto
First line therapy in Entresto arm
• Valsartan
First line therapy in "usual meds" arm

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent with MAP < 85 mmHg	Daily mean arterial pressure (MAP) < 85 mmHg	2 months
Secondary	Number of drugs	Number of anti-hypertensive drugs needed to achieve MAP < 85 mmHg	2 months
Secondary	Pump flow	Correlation of pump flow with daily MAP	2 months