CompletedPhase 4

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

Argentina1,002 participantsStarted 2016-02-12

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization

Timeframe: 10 weeks after Randomization

Trial details

NCT IDNCT02661217

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-20

Results submitted2019-06-20

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials