A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696

ovartis Pharma services AG0 个研究点目标入组 1,980 人开始时间: 2014年11月18日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Written informed consent for the extension must be obtained before any assessment is performed.
•2. Patients who have been enrolled and treated with double-blind study medication in the PARADIGM-HF study (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2600

•1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is
•2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
•3. Known history of angioedema
•4. Requirement of simultaneous treatment with both ACEIs and ARBs 5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
•6. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 (screening)
•7. Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula at Visit 1 (screening)
•8. Presence of bilateral renal artery stenosis
•9. Serum potassium > 5.2mmol/L at Visit 1 (screening)
•10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
•11. Pregnant or nursing (lactating) women
•12. Women of childbearing potential
•13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.

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