Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-08

Study Completion Date

2017-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada

NCT02957409

Heart Failure

COMPLETED

Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes.

NCT02887183

Heart Failure

COMPLETED PHASE4

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

NCT03066804

Heart Failure With Preserved Ejection Fraction

COMPLETED PHASE3

Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

NCT02874794

Heart Failure and Reduced Ejection Fraction

COMPLETED PHASE4

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

NCT01922089

Heart Failure With Reduced Ejection Fraction

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearth Failure With Reduced Ejection Fraction (HFrEF)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LCZ696 (sacubitril / valsartan)

All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.

Group Type OTHER

LCZ696 (sacubitril/valsartan)

Intervention Type DRUG

All patients were treated with the LCZ696 (sacubitril and valsartan) tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LCZ696 (sacubitril/valsartan)

All patients were treated with the LCZ696 (sacubitril and valsartan) tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Age ≥ 18 years and ≤ 80 years.
3. Males or females.
4. Diagnosis of Heart Failure NYHA class II-III.
5. Diagnosis of Heart Failure with reduced Ejection Fraction (LVEF =\< 40%) and NYHA class II or III.
6. Stable on any dose of ACEI or ARB prior to enrolment in the study
7. Stable on any dose of a beta-blocker prior to enrolment in the study.
8. Eligible for treatment with LCZ696 as per Canadian product monograph.
9. Treated as an outpatient.
10. Signed an informed consent agreeing to participate in the study.

Exclusion Criteria

1. Symptomatic hypotension and/or a SBP \< 100 mmHg at baseline visit.
2. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at baseline visit.
3. Known history of angioedema related to previous ACEI or ARBs therapy, or history of hereditary or idiopathic angioedema.
4. Requirement of concomitant treatment with both ACEIs and ARBs.
5. Concurrent participation in other clinical trials or receiving other investigational drugs within 30 days of enrollment.
6. Hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients.
7. 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).
8. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
11. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No