Effectiveness Comparison of Medical Treatment and Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients Concomitant With Adrenal Diseases: A Prospective, Multi-Center, Open-Labeled, Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- A composite of end-point events
研究概览
简要总结
ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The purpose of this study is to compare the effectiveness of medical treatment and unilateral laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal disease based on imaging tools.Relative ratio of end-point events occurence in three years is considered as primary outcome. Furthermore, we will exploit clinical factors which could indicate a favorable outcome in participants who accepted surgical treatment in this study.
详细描述
Resistant hypertension is a clinical condition characterized by the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg in hypertensive patients), despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs, one of which is represented by a diuretic, in adequate doses. Several small-sample studies suggest the prevalence of resistant hypertension is about 5-30% in Chinese population. Uncontrolled blood pressure elevation attributes to a higher incidence of stroke, heart failure, chronic renal disease, dementia and cardiovascular deaths. Improving the management of resistant hypertension is a constantly tricky problem in hypertension clinical practice.
Compared with patients whose blood pressure level are more easily to get controlled, patients diagnosed with resistant hypertension presented a higher risk of adrenal anomaly when screened by imaging tools. Current clinical practice guidance recommend unilateral laparoscopic adrenalectomy as a preferable treatment merely for adrenal incidentalomas with over hormone secreting like cortisol or aldosterone, or a high likelihood of malignance. Among patients who meet above surgery indication, the ratio of cure for hypertension varies from approximately 30 to 80%. However, in recent years, there are growing evidence showed that hypertensive patients diagnosed with adrenal disease based on imaging tools also gain much benefit from adrenalectomy even if there is no evidently abnormal hormone secretion. Last year, a prospective cohort study published on <Ann Intern Med> suggested that "nonfunctional" adrenal tumors associate with increased diabetes risk. These studies prompt a re-assessment of the classification of benign adrenal tumors as "non-functional"and their potential damage.
In a retrospective study conducted by our group in early period to evaluate the effect of surgery treatment in resistant hypertensive patients, we found one third of resistant hypertensive patients were cured as well as another one third get improved after unilateral laparoscopic adrenalectomy. Thus, we designed this study, expecting a further and more detailed perception of the relationship between resistant hypertension and adrenal anomaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Since one of the intervention is invasive surgical operation, the other is conservative medical treatment, the difference between these two intervention is too obvious to mask, no masking are designed in this study.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resistant hypertensive patients diagnosed with adrenal disease based on imaging tools (resistant hypertension defined as the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg),despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs for at least one month, one of which is represented by a diuretic, in adequate doses)
- •Signed the written informed consent.
排除标准
- •Patients with surgical contraindication;(Performed coronary revascularization (PCI or CABG) within the previous 6 months; Cerebral hemorrhagic stroke within the previous 3 months, or new onset cerebral infarction within the latest 2 weeks;Severe heart failure or kidney disfunction within the previous 6 months)
- •Patients who has proceeded unilateral laparoscopic adrenalectomy once;
- •Severe somatic disease such as cancer;
- •Severe cognitive impairment or mental disorder;
- •Participating in other clinical trials.
研究组 & 干预措施
unilateral laparoscopic adrenalectomy
subjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment.
干预措施: unilateral laparoscopic adrenalectomy (Procedure)
standard medical treatment
subjects allocated in standard medical treatment group will be given conservative medicine treatment.
干预措施: standard medical treatment (Drug)
结局指标
主要结局
A composite of end-point events
时间窗: 3 year
A composite end-point comprised of myocardial infarction(MI), congestive heart failure, cerebrovascular event, end stage renal disease, death.
次要结局
- All-cause death(3 years)
- First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)(3 years)
- Major coronary events(3 years)
- Cardiovascular death(3 years)
- myocardial infarction(3 years)
- Hospitalization for unstable angina(3 years)
- Hospitalization for acute decompensated heart failure(3 years)
- Decline in renal functio or development of end stage renal disease (ESRD)(3 years)
- Major artery function changes(3 years)
- coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG])(3 years)
- First occurence of diabetes mellitus(3 years)
- Decline in cognitive function(3 years)
研究者
Jun Cai
Director, Hypertension Center
Chinese Academy of Medical Sciences, Fuwai Hospital