Resistant Hypertension Clinical Trial
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.
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.
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.
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