Resistant Hypertension Clinical Trial
— ULARHOfficial 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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 20, 2021 |
Est. primary completion date | October 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese Academy of Medical Sciences, FuWai Hospital | Beijing | Beijing |
China | Shandong Provincial Hospital | Ji'nan | Shandong |
China | Yunzhou Municiple Hospital | Ji'ning | Shandong |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences, Fuwai Hospital |
China,
Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaïsse B, Villeneuve F, Halimi JM. [Management of resistant hypertension. Expert consensus statement from the French Society of Hypertension, an affiliate of the French Society of Cardiology]. Presse Med. 2014 Dec;43(12 Pt 1):1325-31. doi: 10.1016/j.lpm.2014.07.016. Epub 2014 Nov 20. French. — View Citation
Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467. — View Citation
Lopez D, Luque-Fernandez MA, Steele A, Adler GK, Turchin A, Vaidya A. "Nonfunctional" Adrenal Tumors and the Risk for Incident Diabetes and Cardiovascular Outcomes: A Cohort Study. Ann Intern Med. 2016 Oct 18;165(8):533-542. doi: 10.7326/M16-0547. Epub 2016 Aug 2. — View Citation
Sim JJ, Bhandari SK, Shi J, Reynolds K, Calhoun DA, Kalantar-Zadeh K, Jacobsen SJ. Comparative risk of renal, cardiovascular, and mortality outcomes in controlled, uncontrolled resistant, and nonresistant hypertension. Kidney Int. 2015 Sep;88(3):622-32. doi: 10.1038/ki.2015.142. Epub 2015 May 6. — View Citation
Xu T, Xia L, Wang X, Zhang X, Zhong S, Qin L, Zhang X, Zhu Y, Shen Z. Effectiveness of partial adrenalectomy for concomitant hypertension in patients with nonfunctional adrenal adenoma. Int Urol Nephrol. 2015 Jan;47(1):59-67. doi: 10.1007/s11255-014-0841-8. Epub 2014 Oct 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A composite of end-point events | A composite end-point comprised of myocardial infarction(MI), congestive heart failure, cerebrovascular event, end stage renal disease, death. | 3 year | |
Secondary | Major coronary events | 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. | 3 years | |
Secondary | First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal) | First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal) | 3 years | |
Secondary | All-cause death | All-cause death | 3 years | |
Secondary | Cardiovascular death | Cardiovascular death | 3 years | |
Secondary | myocardial infarction | myocardial infarction | 3 years | |
Secondary | Hospitalization for unstable angina | Hospitalization for unstable angina | 3 years | |
Secondary | Hospitalization for acute decompensated heart failure | Hospitalization for acute decompensated heart failure | 3 years | |
Secondary | coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG]) | coronary revascularization (percutaneous coronary intervention [PCI], coronary bypass grafting [CABG]) | 3 years | |
Secondary | First occurence of diabetes mellitus | First occurence of diabetes mellitus | 3 years | |
Secondary | Decline in cognitive function | Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE) | 3 years | |
Secondary | Decline in renal functio or development of end stage renal disease (ESRD) | 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. | 3 years | |
Secondary | Major artery function changes | 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. |
3 years |
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