Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
研究概览
详细说明
A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were obtained. Inclusion criteria for the study were either gender between 18 to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia, hypotension, renal dysfunction, and a history of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were excluded from the study.
All the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID) for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication adherence level using the Dose-Nonadherence scale. All the patients were kept under a close follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and tolerability outcomes were assessed as per the operational definition.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Sindh
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Karachi、Sindh、巴基斯坦、75510
- National Institute of CardioVascular Diseases
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Either gender
- between 18 to 80 years of age
- Diagnosed with Heart failure with reduced ejection fraction (HFrEF)
- New York Heart Association (NYHA) class II-IV
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Stable on any dose of beta-blockers, ACEI or ARB
Exclusion Criteria:
- Refused to participate in the study
- Patients with hyperkalemia
- Patients with hypotension
- Patients with renal dysfunction
- History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment group
All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.
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All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Incidence of hypotension
大体时间:12 weeks
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Systolic blood pressure <90 mmHg
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12 weeks
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Incidence of renal dysfunction
大体时间:12 weeks
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estimated glomerular filtration rate (eGFR) <30 ml/min
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12 weeks
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Incidence of renal hyperkalemia
大体时间:12 weeks
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Potassium >5.2 mmol/L
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12 weeks
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Incidence of renal angioedema
大体时间:12 weeks
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Rapid edema, or swelling, of the area beneath the skin or mucosa
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12 weeks
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Frequency of tolerability
大体时间:During 12 weeks
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Defined as the dose tolerated by the patients which did not require down titration or discontinuation of prescribed dose during follow-up
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During 12 weeks
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合作者和调查者
调查人员
- 首席研究员:Muhammad Nauman Khan, FCPS、National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ERC-05/2020
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Sacubitril/valsartan的临床试验
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Germans Trias i Pujol Hospital完全的
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Massachusetts General Hospital招聘中
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Guangdong Provincial People's Hospital未知
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University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)招聘中
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Instituto Nacional de Cardiologia Ignacio ChavezBoehringer Ingelheim laboratory尚未招聘
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University of Sao Paulo General HospitalInCor Heart Institute招聘中