Aortic AneurysmDADADNCT06626607
Different Antihypertensive Drugs on Aortic Diseases
An observational study of Aortic Aneurysm and Aortic Dissection, run by Eighth Affiliated Hospital, Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection
- What is being tested?
- CCB use and non-CCB use
- How many people
- 704 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- aortic diseases\' patients underwent aortic surgery who require antihypertensive medication.
Who cannot join
- Patients with active vasculitis;
- Patients allergic to contrast agent
- Patients with aorta variation
About this study
Official title: A Study of the Effect of Different Antihypertensive Drugs on the Disease Progression of Aortic Dissection/Aneurysm
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Being tested
- CCB use, non-CCB use
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCB useDrug
Postoperative antihypertensive medication includes CCB
non-CCB useDrug
Postoperative antihypertensive medication does not include CCB
| Study group | Role | What they receive |
|---|---|---|
| CCB group | Patients' postoperative antihypertensive includes CCB (Calcium Calcium Entry Blockers) Receives: Drug: CCB use | |
| non-CCB group | Patients' postoperative antihypertensive does not include CCB Receives: Drug: non-CCB use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic diameter
The maximum diameter of the aorta measured by computed tomography angiography
Measured: Through the study completion, on an average of 3 years
Secondary outcomes (1)
Number of Participants with adverse aortic event
Postoperative adverse aortic event during follow-up, including aortic related death or reoperation
Measured: Through the study completion, on an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2017
- Primary completion30 May 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Zhang Tingting, Eighth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626607
- Sponsor's protocol ID
- ZB-KYIRB-AF/SC-08/02.0
- Acronym
- DADAD
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators need to consult with the IRB committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Different Antihypertensive Drugs on the Disease Progression of Aortic Dissection/Aneurysm
- ClinicalTrials.gov ID
- NCT06626607
- Acronym / sponsor ID
- DADAD / ZB-KYIRB-AF/SC-08/02.0
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCB group | – | Drug: CCB usePatients' postoperative antihypertensive includes CCB (Calcium Calcium Entry Blockers) |
| non-CCB group | – | Drug: non-CCB usePatients' postoperative antihypertensive does not include CCB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- aortic diseases\' patients underwent aortic surgery who require antihypertensive medication.
Key exclusion criteria (3 listed)
- Patients with active vasculitis;
- Patients allergic to contrast agent
- Patients with aorta variation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCB usePostoperative antihypertensive medication includes CCB | Drug | CCB group |
| non-CCB usePostoperative antihypertensive medication does not include CCB | Drug | non-CCB group |
Primary outcome
Aortic diameter
Time frame: Through the study completion, on an average of 3 years
The maximum diameter of the aorta measured by computed tomography angiography
1 secondary outcome
Number of Participants with adverse aortic event
Time frame: Through the study completion, on an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Undecided. The investigators need to consult with the IRB committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortic Dissection, run by Eighth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic diameter (time frame: Through the study completion, on an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.