Assessment of Right Ventricular Function in Patients withReversible Pulmonary Arterial Hypertension Secondary toPulmonary Thromboembolism.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the echocardiographic findings in patients with CTEPH and acute PTE and at follow up of six months after optimal management.
研究概览
简要总结
Echocardiography in setting of acute PTE and CTEPH is routinely done to assess pulmonary artery pressure and RV function. We propose to study the change in pulmonary artery pressure and RV function after management of PTE and CTEPH. We would also document the presence of PFO in patients with PTE and CTEPH, and its effects on clinical presentation of same including saturation (SaO2) and systemic artery oxygen concentration (PaO2). All these patients would be followed up for six months clinically and with detailed echocardiography.
Methodology:
All patients diagnosed with hemodynamically significant acute PTE and CTEPH during study period will be included after informed written consent.
Hemodynamically significant PTE is defined as either of the following(1) persistent hypotension (< 90 mm Hg for over 15 min) not due to hypovolemia and septic shock, or the need for cardiopulmonary resuscitation, or need for continued support of vasopressors, or hypoxia (SpO2 < 95% on room air); (2) echocardiographic and/or doppler indices suggesting pulmonary hypertension without significant left-heart disease or indices suggestive of right ventricular (RV) dysfunction; (3) Raised biomarkers – BNP and/or NT-pro BNP (in absence of other causes like left heart failure/kidney dysfunction)
The demographic and clinical presentation of patients including relevant investigations will be noted as per the Proforma A & B. A detailed echocardiography with documentation of RV function, pulmonary artery pressure and presence/or absence of patent foramen ovale (PFO) will be done at initial presentation as per Proforma C. PFO will be demonstrated with either of the following methods 1) Contrast echocardiography with or without valsalva 2) Transoesophageal echocardiography (TEE).
The patients will be managed as per the current guidelines. All patients PFO will be followed up for six months. After six months, along with clinical examination, a detailed echocardiography will be done to reassess the RV function and pulmonary artery pressure.
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
- •All patients diagnosed with hemodynamically significant acute PTE and CTEPH during study period will be included after informed written consent.
排除标准
- •Patients who did not give consent.
结局指标
主要结局
To study the echocardiographic findings in patients with CTEPH and acute PTE and at follow up of six months after optimal management.
时间窗: To study the echocardiographic findings in patients with CTEPH and acute PTE and at follow up of six months after optimal management.
次要结局
- To study the prevalence of PFO in patients presenting with acute PTE during study period(To study the effect of PFO on clinical presentation of patients)