Pulmonary arterial hypertension and plasma NEDD 9 in Graves disease and its alteration after normalization of thyroid hormones with antithyroid drugs
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1.To estimate the prevalence of Pulmonary arterial hypertension in Grave’s disease patients and its reversibility with treatment with antithyroid drugs (Thionamides).
研究概览
简要总结
The prevalence of pulmonary arterial hypertension will be assessed by 2D-Echocardiography (mPAP >20mm of Hg) in newly detected Grave’s disease patients presenting to OPD of the Department of Endocrinology, MKCG Medical College & Hospital, Berhampur. They will be treated as per protocol and the normalization of pulmonary arterial pressure will be reassessed after achieving an euthyroid state. The novelty of our study is we will also assess the plasma level of NEDD 9 in newly detected Grave’s disease patients with pulmonary arterial hypertension (PAH) in comparison to the non-PAH group. We will also assess for change in Plasma NEDD 9 level after normalization of pulmonary arterial hypertension to know whether NEDD9 plays any role in pathogenesis in the development of PAH. There is a role of thyroid autoimmunity in the development of pulmonary arterial hypertension. We will look for a correlation between the TSH receptor antibody and the anti-TPO antibody and the development of pulmonary arterial hypertension in newly detected Grave’s disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly detected Graves’ disease patients 2.Age ≥ 18 years.
排除标准
- •1.Preexisting cardiovascular disease (significant valvular heart disease, coronary artery disease, dilated or hypertrophic cardiomyopathy, congestive heart failure, and arrhythmias) 2.History of pulmonary thromboembolism or significant pulmonary disease 3.Autoimmune connective tissue disease (Systemic sclerosis, Antiphospholipid antibody syndrome, Vasculitis, Rheumatoid arthritis) 4.Use of anorectic agents (aminorex, fenfluramine, and dexfenfluramine)
- •Known malignancies that can affect plasma NEDD 9 level (carcinoma of the breast, melanoma, T-cell leukemia, glioblastoma, colorectal carcinoma, Acute myeloid leukemia, chronic myeloid leukemia, Adenocarcinoma of lungs, carcinoma of oropharynx)
- •Non-malignant conditions known to affect plasma NEDD 9 like CVA, Polycystic kidney disease.
- •Infections that can produce secondary pulmonary arterial hypertension like HIV, HCV Infection
- •Pregnancy
- •Current smoker.
结局指标
主要结局
1.To estimate the prevalence of Pulmonary arterial hypertension in Grave’s disease patients and its reversibility with treatment with antithyroid drugs (Thionamides).
时间窗: 1 YEAR
2.To compare the plasma NEDD 9 level in newly diagnosed Grave’s disease patients with pulmonary arterial hypertension and without PAH at baseline.
时间窗: 1 YEAR
3.To compare the plasma NEDD 9 level in newly diagnosed Grave’s disease patients with pulmonary arterial hypertension before and after treatment.
时间窗: 1 YEAR
次要结局
- 1.To look for a correlation of TSH receptor antibody and anti-TPO antibody with pulmonary arterial hypertension in newly diagnosed Grave’s disease patients.(1 YEAR)
研究者
Pradosh Kumar Sahu
MKCG Medical College & Hospital