Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection

NCT03001739 | Unknown Phase 1 DMC

• 1 other identifier: 20160920-9
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting. Conservative therapy of heart rate and blood pressure control in the acute phase is the essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal target for blood pressure in patients with AD so far. The American Heart Association and the Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation Society recommended that the blood pressure should be controlled to no less than 130mmHg. However, there was few large-scale, randomized, controlled studies reported on the effect of different blood pressure control levels on the prognosis of patients with AD. Hence, the intensive control of blood pressure to \<120 mmHg, compared to \<140 mmHg, may improve the patients' outcome. Thus, in this study, the effect of intensive blood pressure control (\<120mmHg) with conventional blood pressure control (\<140mmHg) on the prognosis of ABAD patients will be compared, and to identify the therapeutic efficacy of intensive blood pressure control on the ABAD patients.

Conditions

Blood High Pressure; Aortic Dissection Type B

Outcome Measures

Primary Outcomes (1)

• composite in-hospital adverse outcome

  including death, permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge

  From date of randomization until the date of death from any cause，or permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge, whichever came first, assessed up to 3 months

Secondary Outcomes (3)

• mortality

  6-month and 1-year after onset of the dissection

• ICU length of stay

  From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 months

• re-operation or another endovascular intervention for the same problem

  From date of first intervention until the date of second intervention, assessed up to 12 months

Study Arms (2)

Intensive BP control (<120mmHg)

EXPERIMENTAL

Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to \< 120 mm Hg

Drug: Urapidil Hydrochloride Injection

Conventional BP control (120-140mmHg)

ACTIVE COMPARATOR

Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to 120-140 mm Hg

Drug: Urapidil Hydrochloride Injection

Interventions

Urapidil Hydrochloride Injection DRUG

Urapidil Hydrochloride Injection or other antihypertensive agents to decrease the BP to the target level.

Also known as: Urapidil

Conventional BP control (120-140mmHg); Intensive BP control (<120mmHg)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed patients with Stanford type B acute aortic dissection and systolic blood pressure\>160mmHg

You may not qualify if:

• Age \<18 years,
• In pregnancy,
• Diagnosis of aortic dissection was made 48 hours or more prior,
• Dissection due to aortic intramural hematoma or penetrating atherosclerotic ulcer,
• With history of previous surgical or interventional endovascular treatment for aortic diseases,
• With traumatic aortic injury,
• With history of cerebrovascular accident, brain surgery, chronic renal insufficiency, and mesenteric vascular thrombosis or dissection,
• AD patient concomitant with new cerebral infarction, or ischemic mesenteric artery or lower limb arteries which requiring urgent surgical interventions,
• With obvious contraindications for antihypertensive therapy, such as severe carotid stenosis, cerebral infarction in acute phase ,
• Pathogenesis of the dissection was due to congenital aortic hypoplasia, such as Marfan syndrome, connective tissue diseases.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (1)

• Zhou JC, Zhang N, Zhang ZH, Wang TT, Zhu YF, Kang H, Zhang WM, Li DL, Li WD, Liu ZJ, Qian XM, Zhang MY, Wang J, Zhou M, Yang ZT, Yu YX, Li HY, Zhang J, Wang YG, Gao JP, Ling L, Pan KH; Pressure in Acute Type B Aortic Dissection (RAID) study group. Intensive blood pressure control in patients with acute type B aortic dissection (RAID): study protocol for randomized controlled trial. J Thorac Dis. 2017 May;9(5):1369-1374. doi: 10.21037/jtd.2017.03.180.

  PMID: 28616291 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

urapidil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yun-song Yu, MD

  Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Ying-zhi Fang, MD

CONTACT

+86 571 86006987

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 23, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)