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临床试验/CTRI/2025/08/093843
CTRI/2025/08/093843尚未招募2 期

Effectiveness of nebulized nitroglycerine in patients with right heart failure with severe pulmonary artery hypertension - A prospective,randomized, placebo controlled trial

DrBala Ajay pavan Kumar reddy Kasu1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To evaluate the effectiveness and safety of nebulized nitroglycerine as an adjunctive therapy for managing shortness of breath secondary to severe PAH in right heart failure patients by measuring improvement in dyspnea score..

研究概览

简要总结

This is how i enroll participants ??

Eligible participants will include adult patients (aged 18 years and older) presenting with acute onset of Shortness of breath (SOB) in a confirmed case of  right heart failure(RHF ) with severe PAH ( pulmonary artery hypertension ) will be recruited to the study. The patient will be started on O2 by a non rebreathing mask at 10-15 liters per minute. ECG will be taken to rule out acute MI as the cause of SOB. History of fever, cough with sputum will be recorded and chest will be auscultated crepitations. Bedside chest radiograph will be ordered to rule out pneumonia. Arterial blood gas sample will be obtained simultaneously and results recorded . PaO2 -FiO2 ratio will be documented to rule out ARDS. Cardiologist on call will be requested for POCUS to assess cardiac function.Following findings on POCUS suggest RHF- Right ventricle dilatation, Tricuspid regurgitation, Right ventricular free wall diastolic collapse, Mcconnels sign,abnormal TAPSE values and dilated IVC and pulmonary artery hypertension is measured by systolic pulmonary artery pressure in which

mPAP > 55mm hg indicates severe PAH .Patients included in the study will be explained about the study process and written consent will be taken. Exclusion criteria have contraindication to nitroglycerin therapy, such as allergy, recent use of phosphodiesterase inhibitors, and significant hypovolemia ( IVC diameter less than 1 cm and completely collapsing on deep inspiration).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • Patients who are confirmed cases of right heart failure secondary to severe PAH presenting to emergency department with severe SOB.
  • Patients who have provided with written consent after explaining the intervention
  • Patients with SBP above 100 mmHg.

排除标准

  • 1.known allergies to nitroglycerin 2.hypotension , left heart failure , severe ms 3.ACS , ARDS , severe COPD 4.pregnancy /lactation
  • Inability to provide consent 6 .known methemaoglobinemia.

结局指标

主要结局

To evaluate the effectiveness and safety of nebulized nitroglycerine as an adjunctive therapy for managing shortness of breath secondary to severe PAH in right heart failure patients by measuring improvement in dyspnea score..

时间窗: Outcomes are measured at baseline after giving 3rd dose of nebulization , after 1 and half hour

次要结局

  • To compare vitals , blood gases , lactates , shock index(To compare time on ventilator)

研究者

发起方
DrBala Ajay pavan Kumar reddy Kasu
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr.Bala Ajay pavan Kumar reddy Kasu

Nizams institute of medical sciences

研究点 (1)

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