跳至主要内容
临床试验/NCT04347655
NCT04347655招募中不适用

A Novel Approach to the Assessment of the Systemic Circulation and Left Ventricular Performance in Adults

University of Calgary1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Head-Capacity Curve (HCC)

研究概览

简要总结

Background There are significant limitations in the current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. The investigators' have repurposed the concepts of "systemic vascular conductance" to assess systemic circulation, and the "head capacity principle" to assess LV performance. The investigators' now seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods.

Hypothesis There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function.

Methods The research study will involve a single outpatient visit per subject. The study will take place with the subject supine on a bed/table. The subjects will be instrumented with EKG electrodes and finger blood pressure cuffs. The continuous finger BP device performs a waveform analysis in real-time to determine the non-invasive stroke volume, cardiac output, and blood pressure.

The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes.

Following the handgrip test, the instrumentation will be removed and the patient's participation in the study will be complete. The study duration should be about 20 min.

详细描述

Background There are significant limitations in our current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. Using engineering principles, the investigators' have repurposed 2 concepts to develop novel (and hopefully improved) interpretation of integrated cardiovascular function. These concepts are "systemic vascular conductance" for systemic circulation and the "head capacity principle" for LV performance, which have been demonstrated in animal physiology experiments using a porcine model. In this protocol, the investigators' seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods.

Aims and Hypotheses Primary Aim: To evaluate cardiovascular function in patients with heart failure using a head-capacity relation to assess left ventricular pump function as well as by assessing systemic vascular conductance.

Hypothesis: There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function. In addition, heart failure patients will have decreased systemic vascular conductance.

Specific Aim#1: The investigators' will compare patients with heart failure with reduced ejection fraction (HFrEF) to healthy (no heart failure) control participants.

Specific Aim #2: The investigators' will compare patients with heart failure with preserved ejection fraction (HFpEF) to healthy (no heart failure) control participants.

研究设计

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

入排标准

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

入选标准

  • •Age 18 years or older
  • •Clinical heart failure (HFrEF or HFpEF) for heart failure patients and no clinical heart failure for the non-heart failure participants.

排除标准

  • •Unable or unwilling to provide informed consent
  • •On intravenous inotrope or pressor medications to maintain their cardiac function

研究组 & 干预措施

HFrEF

Experimental

patients with heart failure with reduced ejection fraction

干预措施: handgrip test (Procedure)

HFpEF

Experimental

heart failure with preserved ejection fraction

干预措施: handgrip test (Procedure)

Control

Active Comparator

healthy (no heart failure) control participants

干预措施: handgrip test (Procedure)

结局指标

主要结局

Head-Capacity Curve (HCC)

时间窗: 1 day

systolic arterial blood pressure (SBP) when CI = 4 L/min/m2

次要结局

  • Cardiac Power(1 day)
  • Systemic Vascular Conductance (SVC)(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Satish Raj

Professor of Cardiac Sciences

University of Calgary

研究点 (1)

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