NCT03535532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

May 14, 2018

Last Update Submit

May 14, 2018

Conditions

Resistant HypertensionAdrenal Disease

Keywords

resistant hypertensionAdrenal Diseasemedical treatmentlaparoscopic adrenalectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Major coronary events

    3 years

  • First occurrence of symptomatic stroke (ischemic or hemorrhagic, fatal or nonfatal)

    3 years

  • All-cause death

    3 years

  • Cardiovascular death

    3 years

  • myocardial infarction

    3 years

  • +7 more secondary outcomes

Study Arms (2)

unilateral laparoscopic adrenalectomy

EXPERIMENTAL

subjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment.

Procedure: unilateral laparoscopic adrenalectomy

standard medical treatment

ACTIVE COMPARATOR

subjects allocated in standard medical treatment group will be given conservative medicine treatment.

Drug: standard medical treatment

Interventions

unilateral laparoscopic adrenalectomyPROCEDURE

unilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion.

Also known as: standard medical treatment
unilateral laparoscopic adrenalectomy
standard medical treatmentDRUG

standard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations.

Also known as: unilateral laparoscopic adrenalectomy
standard medical treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chinese Academy of Medical Sciences, FuWai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Shandong Provincial Hospital

Ji'nan, Shandong, 100037, China

Location

Yunzhou Municiple Hospital

Ji'ning, Shandong, China

Location

Related Publications (5)

  • 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.

    PMID: 25945406BACKGROUND

  • 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.

    PMID: 27479926BACKGROUND

  • 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.

    PMID: 25305227BACKGROUND

  • 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.

    PMID: 27390021BACKGROUND

  • Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaisse 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.

    PMID: 25459067BACKGROUND

MeSH Terms

Conditions

Adrenal Gland Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Jun Cai, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY DIRECTOR

Central Study Contacts

Weili Zhang, MD

CONTACT

861088322025zhangweili1747@yahoo.com

Yue Deng

CONTACT

861088322025dy611381@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: resistant hypertensive patients diagnosed with adrenal diseases based on imaging tools will be randomly allocated into unilateral laparoscopic adrenalectomy group and standard medical treatment group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hypertension Center

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

December 20, 2018

Primary Completion

October 20, 2020

Study Completion

December 20, 2021

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

CN(3)