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临床试验/NCT05098665
NCT05098665招募中不适用

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring

Richmond Research Institute2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2025年1月1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
发起方
入组人数
320
试验地点
2
主要终点
Heart-failure related hospitalisations

研究概览

简要总结

Cardiac amyloidosis is a condition where the heart muscle, amongst other tissues, is infiltrated by the abnormal build-up of proteins called amyloid. This stiffens and thickens the heart muscle over time which makes it less efficient and puts further stress and strain on the other chambers of the heart, leading to heart failure. The commonest form, that affects predominantly the elderly, is called 'wild-type' ATTR amyloid (TTR is the protein that accumulates). In this condition a patient has a 60% chance of admission to hospital each year after diagnosis. There is no current treatment for ATTR amyloid other than using water tablets to reduce excess fluid and prevent more serious fluid build up in lungs and other tissues. Increasing body weight is the most reliable clinical sign of this fluid build up.

Tele-monitoring is the practice of monitoring patients from a distance and has been shown to reduce heart failure admissions and death in patients with heart failure from any cause. Due to reduced access to primary and secondary care during COVID-19 the investigators instigated tele-monitoring of heart failure in ATTR amyloid patients. This appeared to be an effective intervention in the pilot study. The investigators propose to monitor the weight of patients with cardiac amyloidosis at home and intervene where a build up of fluid is observed by telephone discussion with a doctor. The investigators propose to evidence this in a prospective clinical trial. The investigators will evaluate the effect fairly by comparing tele-monitoring with usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

It is not possible to mask this type of intervention for participant or care provider, but outcomes will be assessed in a blinded fashion.

入排标准

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

入选标准

  • Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period.
  • An established diagnosis of ATTR cardiomyopathy as defined by protocol.
  • Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any study-related procedures.
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Currently a patient at a study site (NAC).

排除标准

  • An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
  • On dialysis or end-stage renal failure (eGFR <25mL/min)
  • Serum albumin <20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome)
  • Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)

研究组 & 干预措施

Arm B - RCT usual care

No Intervention

Control group of 160 ATTR-CM patients assigned to receive usual care

Arm A - RCT telemonitoring

Active Comparator

160 ATTR-CM patients assigned to receive telemonitoring intervention

干预措施: Telemonitoring service (Combination Product)

结局指标

主要结局

Heart-failure related hospitalisations

时间窗: Study duration (3 years)

Hospitalisation which can be attributed to heart failure

All-cause mortality

时间窗: Study duration (3 years)

Death by any cause, as an annual event rate

次要结局

  • All-cause hospitalisation(Study duration (3 years))

研究者

发起方
Richmond Research Institute
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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