Prospective, Multi-center, Open lAbel, Post-appRovAl Study AImed at Characterizing the Use of LCZ696 at 97 mg Sacubitril / 103 mg Valsartan Bid in Patients With HFrEF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Percentage of Participants on LCZ696 200 mg Bid at Month 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Treated as an outpatient.
- •Signed an informed consent agreeing to participate in the study.
排除标准
- •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.
- •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.
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: LCZ696 (sacubitril/valsartan) (Drug)
结局指标
主要结局
Percentage of Participants on LCZ696 200 mg Bid at Month 6
时间窗: Month 6
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.
次要结局
- Percentage of Participants on LCZ696 200 mg Bid at Month 12(Month 12)
- Percentage of Participants Requiring Down-titration From LCZ696 200 mg(Month 12)
- Percentage of Participants With Down-titration Changes From LCZ696 200 mg During 12 Months of Treatment(Month 12)
- Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12(Baseline, Month 6 and Month 12)
- Time to Each Up-titration to LCZ696 100 mg and LCZ696 200 mg(Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12)
- Median Time to Reach LCZ696 200 mg(Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12)
- Percentage of Participants on Guideline Recommended Dose of Beta-blockers and MRAs Over Time(Baseline, Month 6 and Month 12)