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临床试验/NCT04078425
NCT04078425Unknown早期 1 期

Non Invasive Assessment of Heart Failure

Assiut University0 个研究点目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
主要终点
Role of aldosterone antagonist in treatment of heart failure

研究概览

简要总结

  1. To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction.
  2. Portray the health profile of heart failure patients admitted in internal medicine department either heart failure with reduced ejection fraction or heart failure with preserved ejection fraction.
  3. To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy
  4. Vitamin D and its relation to cardiovascular disease and heart failure.

详细描述

Heart failure (HF) is a growing epidemic related to significant morbidity and mortality.

The prevalence of the disease continuously increases due to the ageing population and success in treating cardiovascular diseases that often precede HF.

Lifetime risk of HF is still high with 20-45% and strongly age-dependent . Structural or functional alterations in the heart lead to reduced cardiac output and rising intracardiac pressures.

The resulting HF syndrome comprises typical symptoms such as dyspnoea, ankle swelling and fatigue .

Heart failure is classified into right sided heart failure and left sided heart failure,the later one is classified to HF with reduced EF (HFrEF) involving patients with an EF< 40% and heart failure with preserved ejection fraction (HFpEF) The proportion of HFpEF seems to be slightly lower than that of HFrEF .

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 (Care Provider)

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

  • clinical diagnosed heart failure dyspnea grade III or IV
  • Heart failure with ejecton fraction ≤40

排除标准

  • Acute coronary syndrome.
  • Active infection
  • Chronic kidney diseased patients
  • Conn's disease

研究组 & 干预措施

HF with preserved EF

Experimental

50patients of heart failure with preserved ejection fration will receive anti.failure treatment(lanoxin,beta blocker,diuretics) for one month with follow up echocardiography before and after

干预措施: Aldosterone Antagonists (Drug)

HF with preserved EF recive eplernone

Experimental

50 patients with heart failure with preserved ejection frationnwill receive traditional anti-failure treatment in addition to aldosterone antagonist (Eplernone) with follow up echocardiography and aldosterone level before and after

干预措施: Aldosterone Antagonists (Drug)

结局指标

主要结局

Role of aldosterone antagonist in treatment of heart failure

时间窗: 6months

To evaluate the effect of aldosterone antagonist on exercise capacity of patients with established and symptomatic HFPEF and to evaluate the effect of aldosterone antagonist on diastolic function (the lateral mitral annular doppler tissue imaging measurments were used for assessment of early diastolic relaxation velocity (E'),ameasure of ventricular relaxation and for calculation of E\\E'.

次要结局

未报告次要终点

研究者

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

salma hamdy mahmoud haridi

Principal investigator

Assiut University

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