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Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event | Clinical Trials | Clareo Health

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Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

NCT02661217•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs \& Symptoms
•2. Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
•3. Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
•4. Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
•5. Meeting one of the following criteria:
•* Patients on any dose of ACEI or ARB at screening
•* ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.

Exclusion Criteria

•1. History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
•2. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
•3. End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
•4. Serum potassium above 5.4 mmol/L at Randomization.
•5. Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
•6. Severe hepatic impairment, biliary cirrhosis and cholestasis

Locations (152)

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

Villa María, Córdoba Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Salta, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Genk, Belgium

Novartis Investigative Site

Huy, Belgium

Key Dates

Start Date

February 12, 2016

Primary Completion Date

February 20, 2018

Completion Date

June 20, 2018

Last Updated

April 26, 2021

Enrollment

1,002

ACTUAL participants

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

LCZ696

DRUG

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Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Pulmonary Hypertension (Diagnosis)+2 more

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RECRUITINGNA

An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

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