Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03279861

Enrollment

Registered

2017-09-12

Start date

2017-11-30

Completion date

2019-11-30

Last updated

2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Hypertension

Brief 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.

Detailed 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.

Interventions

DRUGEntresto

First line therapy in Entresto arm

DRUGValsartan

First line therapy in usual meds arm

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Time spent with MAP < 85 mmHg	2 months	Daily mean arterial pressure (MAP) \< 85 mmHg

Secondary

Measure	Time frame	Description
Number of drugs	2 months	Number of anti-hypertensive drugs needed to achieve MAP \< 85 mmHg
Pump flow	2 months	Correlation of pump flow with daily MAP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026