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临床试验/CTRI/2024/05/068130
CTRI/2024/05/068130尚未招募不适用

Correlation of Right Ventricular diastolic function assessment by echo with six minute walk distance in patients with significant pulmonary artery hypertension

Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年6月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Primary outcome measured in this study will be the distance covered in six minutes and its correlation with echo parameters of right ventricular diastolic function in patient with significant pulmonary artery hypertension

研究概览

简要总结

At the outset, we will obtain necessary approvals, including IRC (Institutional Review Committee), IEC (Institutional Ethics Committee) approval, and registration with CTRI (Clinical Trials Registry - India). Our study will focus on patients aged between 18 and 65 years, with echo suggestive of Significant pulmonary artery hypertension (TR velocity > 3.4m/s) in Kasturba Hospital, Manipal. Before the study, we will approach these patients and provide a detailed explanation of the research. Upon their understanding and agreement, informed consent will be obtained. Demographic details, clinical, laboratory valves and treatment receiving will be collected using proforma. Standard echocardiographic parameters which are required for the study will be recorded. They are advised to undergo six minute walk distance as per the ATS guidelines, under the supervision of certified cardiac rehabilitation physiotherapist and Cardilogy DM resident. Following this, Correlation of 6 minute walk distance with various 2d echo parameters of RV function will be analysed. There will be no need for additional visits or follow-up in this study. When standard protocols are followed, complications are rare. As noted previously, the self-paced character of the test limits their occurrence. The most common adverse event reported in the literature is oxygen desaturation below

80% resulting in termination of the test. Other complications include fatigue and mild shortness of breath, however patient will be doing six minute walk at his own pace. if such complications occur, he or she will be asked to stop the walk, as the six minute distance was under the supervision of certified cardiac rehabilitation physiotherapist and Cardilogy DM resident. The six minute walk test is routinely done in OPD settings to know functional capacity of patient.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between age group of 18 – 65 years with echo suggestive of significant pulmonary hypertension (TR velocity ≥ 3.4m/s) without pulmonary stenosis.
  • 2.Patients with Type 1, 4, and 5 Pulmonary Artery Hypertension.

排除标准

  • Patients with locomotion disorder.
  • Patients with Anemia [Hb less than 10.0 g/dl ].
  • Pregnant patients.
  • Doppler echo showing e and a fusion.
  • Not willing to give consent.

结局指标

主要结局

Primary outcome measured in this study will be the distance covered in six minutes and its correlation with echo parameters of right ventricular diastolic function in patient with significant pulmonary artery hypertension

时间窗: Primary outcome measured in this study will be the distance covered in six minutes and its correlation with echo parameters of right ventricular diastolic function in patient with significant pulmonary artery hypertension at the time of visit to the hospital. There will be no need for additional visits or follow ups in this study.

次要结局

  • Distance covered in six minutes & its correlation with echo parameters of right ventricular systolic function in patient with significant pulmonary artery hypertension(Distance covered in six minutes & its correlation with echo parameters of right ventricular systolic function in patient with significant pulmonary artery hypertension at the time of visit to the hospital. There will be no need for additional visits or follow ups in this study.)

研究者

发起方
Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Utukuru Nithin Kumar Reddy

Kasturba Medical College, Manipal

研究点 (1)

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