NO_LONGER_AVAILABLENot Applicable

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

United States, Australia, Austria

Plain-language summary

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.
✓. Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:
✓. Patient had a hospitalization for HF within the last 12 months
✓. Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696
✓. Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).
✓. An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

Exclusion criteria

✕. The patient is eligible for participation in any of the IMP's ongoing clinical trials
✕. The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.
✕. The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation
✕. History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696
✕. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
✕. Previous history of intolerance to recommended target doses of ARBs
✕. Known history of angioedema
✕. Requirement of concomitant treatment with both ACEIs and ARBs

Trial details

NCT IDNCT02389933

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction (HF-rEF) trials