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临床试验/CTRI/2021/04/032858
CTRI/2021/04/032858招募中4 期

Digoxin in patients with rheumatic heart disease - a randomised placebo-controlled trial

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Age >= 18 years
  • 2. RHD documented by echocardiography
  • 3. Already on treatment with digoxin as advised
  • by their treating doctors
  • 4. Not already on digoxin, but haveeither of
  • the following conditions:
  • i. Heart failure - diagnosed in the presence
  • of current or past clinical symptoms
  • (limitation of activity, fatigue, and
  • dyspnea, orthopnea or paroxysmal nocturnal
  • dyspnea), signs (edema, elevated jugular
  • venous pressure, or rales), or radiologic
  • evidence of pulmonary congestion
  • ii. Atrial fibrillation or flutter -documented
  • on a 12-lead ECG

排除标准

  • 1. Significant renal insufficiency (serum
  • creatinine >2 mg/dL)
  • 2. Uncorrected hypokalemia ( <3.2 mmol/L) or
  • hyperkalemia ( >5.5 mmol/L)
  • 3. Presence of sinus bradycardia (HR <50/min),
  • II or III degree AV block, sick sinus
  • syndrome or pre-excitation
  • 4. Physician does not wish to start digoxin
  • 5. Coexisting coronary artery disease or other
  • cardiac conditions (hypertrophic, dilated or
  • restrictive cardiomyopathies)
  • 6. Patients with mechanical heart valves
  • (however, patients who undergo mechanical
  • valve replacement surgery during the course
  • of the study will be continued on study
  • 7. Pregnant women
  • 8. Presence of severe comorbid conditions which
  • may limit life expectancy to <2 years

研究者

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