Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejec… (NCT02690974) | Clinical Trial Compass
CompletedPhase 4
Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting
Canada302 participantsStarted 2016-03-08
Plain-language summary
The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada.
The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.
Who can participate
Age range
18 Years – 80 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
. Written informed consent must be obtained before any assessment is performed.
. Age ≥ 18 years and ≤ 80 years.
. Males or females.
. Diagnosis of Heart Failure NYHA class II-III.
. Diagnosis of Heart Failure with reduced Ejection Fraction (LVEF =\< 40%) and NYHA class II or III.
. Stable on any dose of ACEI or ARB prior to enrolment in the study
. Stable on any dose of a beta-blocker prior to enrolment in the study.
. Eligible for treatment with LCZ696 as per Canadian product monograph.
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.
What they're measuring
1
Percentage of Participants on LCZ696 200 mg Bid at Month 6
. Symptomatic hypotension and/or a SBP \< 100 mmHg at baseline visit.
. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at baseline visit.
. Known history of angioedema related to previous ACEI or ARBs therapy, or history of hereditary or idiopathic angioedema.
. Requirement of concomitant treatment with both ACEIs and ARBs.
. Concurrent participation in other clinical trials or receiving other investigational drugs within 30 days of enrollment.
. Hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients.
. Concomitant use of aliskiren-containing drugs in patients with diabetes mellitus (type 1 or type 2) or moderate to severe renal impairment (GFR \<60ml/min/1.73m\^2).
. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.