Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients With Adrenal Diseases

Not Applicable

• Conditions: Resistant Hypertension; Adrenal Disease
• Interventions: Drug: standard medical treatment; Procedure: unilateral laparoscopic adrenalectomy

• Registration Number: NCT03535532
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-24
• Last Update Posted: 2018-05-24
• Study Start: 2018-12-20
• Primary Completion: 2020-10-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. 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)
2. Signed the written informed consent.

Exclusion Criteria

1. 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)
2. Patients who has proceeded unilateral laparoscopic adrenalectomy once;
3. Severe somatic disease such as cancer;
4. Severe cognitive impairment or mental disorder;
5. Participating in other clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard medical treatment	standard medical treatment	subjects allocated in standard medical treatment group will be given conservative medicine treatment.
unilateral laparoscopic adrenalectomy	unilateral laparoscopic adrenalectomy	subjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment.

Primary Outcome Measures

Name	Time	Method
A composite of end-point events	3 year	A composite end-point comprised of myocardial infarction(MI), congestive heart failure, cerebrovascular event, end stage renal disease, death.

Secondary Outcome Measures

Name	Time	Method
First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)	3 years	First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)
All-cause death	3 years	All-cause death
Major coronary events	3 years	Major coronary events comprised of myocardial infarction (MI), hospitalization for unstable angina or acute decompensated heart failure, coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass grafting \[CABG\]), and death from cardiovascular causes.
Hospitalization for unstable angina	3 years	Hospitalization for unstable angina
Hospitalization for acute decompensated heart failure	3 years	Hospitalization for acute decompensated heart failure
Decline in renal functio or development of end stage renal disease (ESRD)	3 years	Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR\<60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of EDRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decreased in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.
Major artery function changes	3 years	Major artery function changes are assessed by a composite of decrease in the ankle branchial index \[ABI\], brachial-ankle pulse wave velocity(baPWV),or brachial artery flow-mediated dilation \[FMD\].; ABI and baPWV, well-established non-invasive techniques fr evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.; FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodialator function in humans and is regarded as a surrogate marker of cardiovascular disease.
coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG])	3 years	coronary revascularization (percutaneous coronary intervention \[PCI\], coronary bypass grafting \[CABG\])
First occurence of diabetes mellitus	3 years	First occurence of diabetes mellitus
Decline in cognitive function	3 years	Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
Cardiovascular death	3 years	Cardiovascular death
myocardial infarction	3 years	myocardial infarction

Trial Locations

Locations (3)

Chinese Academy of Medical Sciences, FuWai Hospital; 🇨🇳 Beijing, Beijing, China

Shandong Provincial Hospital; 🇨🇳 Ji'nan, Shandong, China

Yunzhou Municiple Hospital; 🇨🇳 Ji'ning, Shandong, China