Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03535532
Status:
UNKNOWN
Last Update Posted:
2018-05-24
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients With Adrenal Diseases
Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Organization:
Study Overview
Official Title:
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.
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULARH
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: