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

NO_LONGER_AVAILABLE

Conditions studied: Heart Failure With Reduced Ejection Fraction (HF-rEF)

In brief

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.

Key facts

Study ID

NCT02389933

Run by

Novartis Pharmaceuticals

Last updated by the study team

2021-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient(s) for whom the MPP is sought meets all of the following:
• Is suffering from a serious or life-threatening disease or condition
• Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
• Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;
• Intolerance to evidence-based target doses should be documented by the treating physician
• Meets any other relevant medical criteria for compassionate use of the investigational product
• Patients eligible for inclusion in this program have to fulfill all of the following 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:
• LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)
• 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

You may not qualify if…

• Patients fulfilling any of the following criteria are not eligible for inclusion in this program:
• 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
• Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
• Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696
• Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula
• Presence of bilateral renal artery stenosis
• Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696
• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696
• Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.
• Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.
• Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD
• History of severe pulmonary disease
• Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696
• Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696
• Symptomatic bradycardia or second or third degree heart block without a pacemaker
• Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation
• Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis

Where it is running

• Novartis Investigative Site — Darlinghurst, New South Wales, Australia
• Novartis Investigative Site — North Ryde, New South Wales, Australia
• Novartis Investigative Site — Perth, Western Australia, Australia
• Novartis Investigative Site — Krems, Austria
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Sankt Pölten, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Fortaleza, Ceará, Brazil
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Varaždin, HRV, Croatia
• Novartis Investigative Site — Limassol, Cyprus
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Nicosia, Cyprus
• Novartis Investigative Site — Marseille, Bouches Du Rhone, France
• Novartis Investigative Site — Bron, Cedex, France
• Novartis Investigative Site — Caen, Cedex, France
• Novartis Investigative Site — Saint-Denis, France / La Reunion, France
• Novartis Investigative Site — Vero Beach, Florida, United States

Full record on ClinicalTrials.gov

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