CZ696 in heart failure patients with reduced ejection fraction and high comorbidity: effect on left ventricular remodeling and fibrosis assessed by novel heart failure biomarkers and cardiac magnetic resonance - LCZ696-17 Study

FIMABIS0 个研究点目标入组 68 人开始时间: 2017年9月18日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•- Patients must give written informed consent before any assessment is performed.
•- Outpatients = 18 years of age, male or female.
•-Diagnosis of chronic heart failure NYHA class II-IV with reduced ejection fraction (EF =< 40%) and elevated NT-proBNP = 600 pg/mL, but 400 pg/mL if hospitalized for heart failure within 12 months.
•- Charlson Index = 5.
•- The patients must be treated with angiotensin-converting-enzyme inhibitor (ACEI) or an angiotensin-converting-enzyme inhibitor (ARB), ß-blocker and mineralocorticoid antagonist receptor unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
•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 68
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 68

•- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or neprilysin inhibitors as well as known or suspected contraindications to the study drugs.
•- Previous history of intolerance to recommended target doses of ACEIs or ARBs.
•- Known history of angioedema.
•- Requirement of treatment with both ACEIs and ARBs
•- Current acute decompensated heart failure (exacerbation of chronic heart failure manifested by signs and symptoms that may require intravenous therapy).
•- Symptomatic hypotension and/or a SBP < 100 mmHg
•- Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) Study equation.
•- Serum potassium > 5.2 mmol/L.
•- Participation in clinical trial with another drug within 30 days of first study visit.

发起方

FIMABIS