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Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)

NCT02788656 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-02-17

Study results available
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Summary

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).

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Implantable Hemodynamic Monitor

The CardioMEMS device is an implantable pulmonary artery pressure monitor that is FDA-approved for use in patients with symptomatic heart failure and previous heart failure hospitalization. Patients eligible for this study are those with an already implanted CardioMEMS device.

DRUG

Angiotensin-Converting Enzyme Inhibitor

Conventional, guideline-directed therapy for heart failure and reduced ejection fraction

DRUG

Angiotensin II Type 1 Receptor Blocker

Conventional, guideline-directed therapy for heart failure and reduced ejection fraction in ACE-inhibitor intolerant patients

DRUG

sacubitril/valsartan

Angiotensin-neprilysin inhibitor that is now FDA-approved and guideline-directed therapy for patients with symptomatic heart failure and reduced ejection fraction despite treatment with an ACE-inhibitor/Angiotensin-Receptor Blocker

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Lauren G Gilstrap, MD · Brigham & Womens' Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-11-09
Completion
2018-11-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788656 on ClinicalTrials.gov