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临床试验/CTRI/2020/03/023681
CTRI/2020/03/023681尚未招募不适用

CARDIOVASCULAR MANIFESTATIONS IN PATIENTS WITH THYROID DYSFUNCTION

MAULANA AZAD MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To study the prevalence of cardiovascular manifestations in patients of thyroid dysfunction

研究概览

简要总结

Purpose of the trial :- To study various cardiovascular manifestations in patients with thyroid dysfunction.

Objectives:

PRIMARY OBJECTIVES:

•       To study the prevalence of cardiovascular manifestations in patients of thyroid dysfunction

•       To study the effect of treatment on the cardiovascular manifestations in these patients

SECONDARY OBJECTIVES:

•       To study the effect of treatment on metabolic profile in patients with thyroid disorders

•       To study the effect of treatment on NT Pro BNP levels in patients with thyroid disorders

Some major findings and references:

  1. In a study conducted by M.Schultz et al,  NT-pro-BNP levels were more than four times higher in hyperthyroid than hypothyroid patients, with mean values of 30 and 7 pmol/l, respectively ( P < 0·001). Serum NT-pro-BNP levels correlated to the thyroid function ( vs. free T4 estimate: r = 0·52, P < 0·0001, n = 57). Treatment resulted in significant increases in NT-pro- BNP in both hypothyroid groups, and decreases in both hyperthyroid groups.

  2. Regarding hyperthyroidism, in one study conducted by Hailu Abera Mulatu, Echocardiographic abnormalities were detected in half (50.7%) of the patients. The study showed that (18.5%) patients had heart failure at initial presentation with the most common cardiovascular manifestations being exertional dyspnea (54.8%), pitting edema (18.5%) and elevated jugular venous pressure (15.8%). Nearly half (48.6%) of the patients had hypertension, and atrial fibrillation was seen in 11% of patients.(4.1%) patients had heart failure with reduced ejection fraction while another (4.1%) patients had isolated right sided heart failure. Pulmonary hypertension with pulmonary artery systolic pressure of 35 mmHg or more was found in (37%) patients.

  3. Regarding hypothyroidism, in a study by Preshant Shrivastava, more than 65% subjects were found to have clinically significant cardiovascular changes. ECG changes observed were Sinus bradycardia in 35.5%, Low voltage complexes in 16.6%, T Wave inversion in 7.8%, RBBB in 4.4%, and QTc prolongation in 2.2% cases. About 64% cases had changes as observed in echocardiographic examination. Most common finding was Diastolic dysfunction seen in 20% cases. This was followed by Pericardial Effusion and Increased IVSD thickness in 16.6% cases each. Increased LVPW thickness was seen in 11.1% cases.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Patients falling into the categories of hyperthyroidism, subclinical hypothyroidism and hypothyroidism.

排除标准

  • •Known case of Diabetes Mellitus
  • •Known case of Coronary Artery Disease, COPD (Previously diagnosed), Chronic Kidney Disease(Previously diagnosed), and Chronic Liver Disease(Previously diagnosed)
  • •Pateints taking drugs which affect thyroid function 4.

结局指标

主要结局

To study the prevalence of cardiovascular manifestations in patients of thyroid dysfunction

时间窗: Less than or equal to One year

次要结局

  • To study the effect of treatment on the metabolic profile in patients with thyroid disorders(Less than or equal to One year)
  • To study the effect of treatment on NT ProBNP Levels in pateints with thyroid disorders(Less than or equal to One year)

研究者

申办方类型
Government medical college

研究点 (1)

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