NCT03279861

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 6, 2023

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

September 8, 2017

Last Update Submit

May 4, 2023

Conditions

Congestive Heart FailureHypertension

Outcome Measures

Primary Outcomes (1)

  • Time spent with MAP < 85 mmHg

    Daily mean arterial pressure (MAP) \< 85 mmHg

    2 months

Secondary Outcomes (2)

  • Number of drugs

    2 months

  • Pump flow

    2 months

Study Arms (2)

Entresto

ACTIVE COMPARATOR

First-line anti-hypertensive: sacubitril-valsartan, starting at 24-26 mg twice daily, increasing to maximum dose of 97-103 mg twice daily

Drug: EntrestoDrug: Valsartan

Usual meds

ACTIVE COMPARATOR

First-line anti-hypertensive: valsartan, starting at 40 mg twice daily, increasing to a maximum dose of 160 mg twice daily

Drug: EntrestoDrug: Valsartan

Interventions

EntrestoDRUG

First line therapy in Entresto arm

EntrestoUsual meds
ValsartanDRUG

First line therapy in "usual meds" arm

EntrestoUsual meds

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 30 days after LVAD implant
  • Ambulatory
  • MAP \> 85 mmHg requiring initiation of anti-hypertensive medications

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureHypertension

Interventions

sacubitril and valsartan sodium hydrate drug combinationValsartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Van-Khue Ton, MD PhD

    University of Maryland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

May 6, 2023

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share