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临床试验/NCT05633563
NCT05633563已完成4 期

The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis

Steen Hvitfeldt Poulsen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10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
已完成
发起方
入组人数
24
试验地点
1
主要终点
Change: pulmonary capillary wedge pressure (PCWP)

研究概览

简要总结

Wild-type transthyretin cardiac amyloidosis (ATTRwt) is a deposition disorder in which one of the proteins of the body misfolds and accumulates at various places in the body, including the heart, leading to both mechanical and cellular damage. The gradual development of the disease will ultimately lead to heart failure and death

The protein which deposits in the heart of patients, damages both the heart mechanically as the myocardium becomes rigid and hypertrophic over time but also at the cellular level. Cell damage can be observed by elevated blood tests for cell damage (Troponin) and during exercise tests that show patients' hearts burning oxygen inefficiently when exposed to physical stress compared with the hearts of healthy individuals . No one has, however, intimately studied this cellular damage.

Vastarel® (Trimetazidine, TMZ) is an already known drug for the treatment of chest pain. The mechanism of action indicates that it may have an effect on patients with cardiac amyloidosis.

The study aims to investigate the effects of TMZ on the mitochondrial function, myocardial performance, and invasive hemodynamics in patients with ATTRwt with a randomized, double-blinded, crossover-trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Wild-type transthyretin cardiac amyloidosis
  • NAC stage I
  • NYHA class of I or II
  • Informed consent

排除标准

  • Other, similar diagnoses
  • Hereditary transthyretin cardiac amyloidosis
  • Light chain amyloidosis
  • Morbus Waldenstrøm
  • Myelomatosis
  • Medical treatment with loop diuretics in standard doses (40 mgx1 daily)
  • Contraindications to trimetazidine
  • Significant comorbidity assessed by the investigators
  • Unable to provide informed consent

研究组 & 干预措施

Active Drug

Active Comparator

Study participants receiving Trimetazidine

干预措施: Trimetazidine (Drug)

Placebo

Placebo Comparator

Study participants receiving placebo (calcium)

干预措施: Placebo (Drug)

结局指标

主要结局

Change: pulmonary capillary wedge pressure (PCWP)

时间窗: Four weeks of treatment

We hypothesize a change in PCWP of 5 mmHg between the active drug and placebo using right heart catheterization.

次要结局

  • Change: cardiac index (CI)(Four weeks of treatment)

研究者

发起方
Steen Hvitfeldt Poulsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steen Hvitfeldt Poulsen

Professor, PhD, DMSci

Aarhus University Hospital Skejby

研究点 (1)

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