Different Antihypertensive Drugs on Aortic Diseases | NCT06626607

Studies
Different Antihypertensive Drugs on Aortic Diseases

NCT06626607

Sponsor

Eighth Affiliated Hospital, Sun Yat-sen University

Status

Completed

Last Update Posted

Oct 4, 2024Actual

Enrollment

704Actual

Phase

Not provided

Conditions

Aortic Aneurysm
Aortic Dissection

Interventions

CCB use
non-CCB use

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Oct 2, 2024

First Posted Date

Oct 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2024

Last Update Posted Date

Oct 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Tingting, Professor, Eighth Affiliated Hospital, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Eighth Affiliated Hospital, Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
Beijing Anzhen Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the effect of different hypotensive drugs on the prognosis of postoperative aortic patients. The main question it aims to answer is:

Does different hypotensive drugs influence the prognosis of postoperative aortic patients? As participants already taking hypotensive drugs as part of their regular medical care, the investigators collect the participants' pre-operation medical record and post-operative follow-up record to evaluate the aorta condition.

Detailed Description

This study is a cohort study that aims to explore the effects of different antihypertensive regimens on aortic remodelling in patients after aortic surgery by collecting the hospitalization and outpatient follow-up data. The study plans to gather perioperative and postoperative follow-up data from over 600 patients who underwent aortic surgery at the Eighth Affiliated Hospital and Beijing Anzhen Cardiothoracic Surgery Center. Patients were assigned based on the postoperative antihypertensive medication regimens. Datas was collected to compare the cardiovascular-related prognoses.

This study primarily includes patients who take oral antihypertensive medications after aortic surgery. The main observations will focus on postoperative complications related to the aorta (such as death, reoperation, dilation, etc.) and aortic diameters after the administration of different antihypertensive medications. Multivariate regression analysis will be employed to investigate the impact of different antihypertensive regimens on patients after aortic surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

704Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CCB group		Patients' postoperative antihypertensive includes CCB (Calcium Calcium Entry Blockers)	Drug: CCB use
non-CCB group		Patients' postoperative antihypertensive does not include CCB	Drug: non-CCB use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCB use	Drug	Postoperative antihypertensive medication includes CCB	CCB group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aortic diameter	The maximum diameter of the aorta measured by computed tomography angiography	Through the study completion, on an average of 3 years

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with adverse aortic event	Postoperative adverse aortic event during follow-up, including aortic related death or reoperation	Through the study completion, on an average of 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aortic diseases' patients underwent aortic surgery who require antihypertensive medication.

Exclusion Criteria:

Patients with active vasculitis;
Patients allergic to contrast agent
Patients with aorta variation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From January 1, 2017 to December 1, 2023, 704 patients with hypertention underwent aortic surgery in the institutions. These patients have complete medical records and follow-up data.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The investigators need to consult with the IRB committee.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001014	Aortic Aneurysm
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided