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临床试验/NCT05217342
NCT05217342招募中4 期

Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure

Marmara University5 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
586
试验地点
5
主要终点
Primary combined end point

研究概览

简要总结

The investigators hypothesize that a simple assessment of peripheral venous pressure (PVP) will better predict the diuretic need and long-term outcomes (all cause mortality, all cause rehospitalization, emergency department visits) compared to standard evaluation.

详细描述

I. BACKGROUND AND SIGNIFICANCE

Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure (HF). Unfortunately, no clear guidelines are present for in-hospital management of congestion. Consequently, nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion. This contributes to high rates of readmission and mortality.

Recently, it has been shown that a simple assessment of peripheral venous pressure (PVP) demonstrates a high correlation with central venous pressure (CVP), indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy.

II. THE HYPOTHESIS

The investigators hypothesize that a simple assessment of peripheral venous pressure (PVP) will better predict the diuretic need and long-term outcomes (all cause mortality, all cause rehospitalization, emergency department visits) compared to standard evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control

Active Comparator

Standard medical therapy arm

干预措施: Diuretic therapy (Drug)

PVP-Guided

Experimental

Peripheral venous pressure guided therapy arm

干预措施: Diuretic therapy (Drug)

结局指标

主要结局

Primary combined end point

时间窗: One year

The difference in the combined rate of all-cause mortality, all-cause hospitalization and all-cause emergency department visits

次要结局

  • Secondary combined end point(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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