Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Fa… (NCT02389933) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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