跳至主要内容
临床试验/NCT05519046
NCT05519046招募中不适用

Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas

InCor Heart Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月25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
60
试验地点
2
主要终点
QoL Score

研究概览

简要总结

Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC.

The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.

详细描述

Chagas Disease:

Chagas disease (Trypanosomiasis Americana) is caused by the protozoan parasite Trypanosoma cruzi, which is transmitted to humans through the feces of a hematophagous insect (family Triatominae) in most cases. The infection usually occurs in childhood, and the acute phase has an incubation period of 1 to 2 weeks and can last up to 3 months. Then follows the chronic phase, in which for a long time - 2-4 decades most of the time - patients have only positive serology for Chagas disease (CD), without symptoms or other signs of clinically apparent disease.

Therefore, such patients present the so-called indeterminate form of Chagas disease, whose prognosis is essentially benign.

While due to pathogenic mechanisms still incompletely understood, many patients remain with this form of the disease for life around 30 to 50% of infected individuals evolve to certain forms like cardiac, digestive, or mixed. Chronic Chagas cardiomyopathy (CCC) has a hemodynamic pattern like dilated idiopathic cardiomyopathy but has marked pathophysiological peculiarities. The most common and most serious clinical form of CD is responsible for significant morbidity and mortality in many Latin countries -Americans (and with epidemiological relevance also contemporarily recognized in countries with immigration by individuals from those countries).

It is estimated that 8-10 million people are infected with Trypanosoma cruzi in Latin America and other countries. Considering the worst-case scenario, we can deduce that 3-5 million infected individuals will manifest clinical forms of the disease in its chronic phase.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signing of an informed consent form (ICF) before randomization and any study procedure,
  • Both genders, age >18 years and <75 years,
  • Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),
  • NYHA II-III heart failure functional class,
  • LVEF< 35%,
  • Non left bundle branch block
  • Intraventricular desynchrony (Yu index)
  • Global longitudinal strain >11 %.

排除标准

  • Participation in another study, presently or terminated <1 year ago, except for a totally unrelated observational study,
  • Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
  • Kidney dysfunction (serum creatinine >1.5mg/dL or eGFR <30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) > 3x the upper limit of normality,
  • Moderate or severe chronic obstructive pulmonary disease,
  • Peripheral polyneuropathy,
  • Hyperthyroidism,
  • Current alcoholism or not abandoned for >2 years,
  • Diagnosed with psychopathy or psychosis or addiction to illicit drugs,
  • Life expectancy <1 year, due to the disease itself or comorbidities (including NYHA class IV),
  • Pregnancy or breastfeeding,
  • Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process),
  • Previously withdrawn from this study.

研究组 & 干预措施

Cardiac Resynchronization Therapy Group - CRT Group

Active Comparator

CRT implantation

干预措施: CRT (Device)

Cardiac Contractility Modulation Group - CCM Group

Experimental

CCM implantation.

干预措施: Cardiac Contractility Modulation (CCM) (Device)

结局指标

主要结局

QoL Score

时间窗: At 6 months

KCCQS - Kansas City cardiomyopathy quality score

GLS

时间窗: At 6 months

Global longitudinal strain at rest/effort - (tissue tracking)

次要结局

  • Heart Failure Hospitalization (HFH) checklist(Through study completion, an average of 6 months)
  • 6MWT(At 6 months)
  • LVEF(At 6 months)
  • NYHAFC(At 6 months)

研究者

发起方
InCor Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martino Martinelli Filho

Principal Investigator

InCor Heart Institute

研究点 (2)

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