Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients
2020年4月20日 更新者:Hospital de Clinicas de Porto Alegre
Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients
One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate.
A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed.
This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF.
研究概览
详细说明
A PROBE (prospective randomized open blinded endpoint) parallel-group design will be used.
Adult patients with a diagnosis of reduced ejection fraction HF, who are being treated at a specialized HF clinic are being recruited.
Those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial.
Participants in the intervention group (IG) shall have their diuretic doses adjusted in accordance with the AAD and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction).
Participants in the control group (CG) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls.
Patients in both groups shall return at 1 month for face-to-face reassessment.
The study endpoints shall comprise readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.
All participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit.
Overall, 135 patients are expected to be enrolled in each group.
研究类型
介入性
注册 (实际的)
206
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Rio Grande Do Sul
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Porto Alegre、Rio Grande Do Sul、巴西、90035 903
- Hospital de Clinicas de Porto Alegre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients of both genders
- Age ≥ 18 years
- Diagnosed with systolic HF
- Able to monitor body weight at home
- Using furosemide
Exclusion Criteria:
- Those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Control Group
In the control group, patients just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
The patients do not receive phone calls neither advising on non-pharmacological treatment; The medication is adjusted by the doctor during the initial evaluation of study baseline.
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This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
其他名称:
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实验性的:Furosemide and Phone contact
The intervention group is conducted by a nurse in a systematic way during one time per week.
If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided.
According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day.
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The intervention group is conducted by a nurse in a systematic way during one time per week.
If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided.
According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day (1 tablet equivalent to 40 milligrams of furosemide)
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 |
大体时间 |
|---|---|
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Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.
大体时间:90 days
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90 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Eneida R Rabelo da Silva, ScD、HCPA and UFRGS
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Feijo MK, Ruschel KB, Bernardes D, Ferro EB, Rohde LE, Biolo A, Rabelo da Silva ER. Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):288-297. doi: 10.1177/1357633X211009640. Epub 2021 May 9.
- Feijo MK, Biolo A, Ruschel KB, Orlandin L, Aliti GB, Rabelo-Silva ER. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:44. doi: 10.1186/s13063-015-0559-7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年5月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2014年2月17日
首先提交符合 QC 标准的
2014年2月20日
首次发布 (估计)
2014年2月21日
研究记录更新
最后更新发布 (实际的)
2020年4月22日
上次提交的符合 QC 标准的更新
2020年4月20日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.