PsoriasisNCT06075394
Hypertension, Antihypertensive Medication Use, and Risk of Psoriasis
An observational study of Psoriasis, run by Xijing Hospital at 1 site in China.
Trial summary
The influences of hypertension and antihypertensive medication on psoriasis have been long discussed. Given the limited and inconsistent evidence available, there is a need to further explore and clarify the relationship between hypertension and psoriasis, as well as to assess the relationship between antihypertensive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- How many people
- 9,294 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators conducted a retrospective cohort study of psoriasis patients (≥18 years old) admitted as inpatients of Xijing hospital. Prior to the commencement of the survey, the investigators underwent collective training on data collection procedures to ensure the quality and reliability of the data. The study population included psoriasis patients aged 18 years or older who had been hospitalized at least once between 2012 and December 2022. Healthy individuals being randomly selected healthy individuals from a medical examination center.
Who may be able to join
- Age ≥18 years;
- Clear diagnosis of psoriasis
Who cannot join
- Age <18;
- Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases;
- Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Antihypertensive Medication Usage on the Status of Psoriasis in Patients Concurrently Having Hypertension.
The influences of hypertension and antihypertensive medication on psoriasis have been long discussed. Given the limited and inconsistent evidence available, there is a need to further explore and clarify the relationship between hypertension and psoriasis, as well as to assess the relationship between antihypertensive medication use and the development or worsening of psoriasis symptoms. The aim of this retrospective study was to analyze data from electronic health records in a large population-based cohort, and the investigators aimed to investigate whether there was a significant association between hypertension and the use of related antihypertensive medications, such as ACEis, and psoriasis, and to explore potential confounders that may influence this association. Understanding the potential relationship between antihypertensive medication and psoriasis is critical, as this may have implications for the management of hypertension in patients with psoriasis or those at risk of developing the condition. This study will contribute to the existing body of evidence and provide valuable insights for clinicians to make informed decisions about the use of antihypertensive medication in this patient population, ultimately contributing to more effective prevention and management strategies for individuals affected by these diseases.
Read the detailed description
The investigators conducted a retrospective cohort study of psoriasis patients (≥18 years old) admitted as inpatients of Xijing hospital. Prior to the commencement of the survey, the investigators underwent collective training on data collection procedures to ensure the quality and reliability of the data. The study population included psoriasis patients aged 18 years or older who had been hospitalized at least once between 2012 and December 2022. Healthy individuals being randomly selected healthy individuals from a medical examination center. According to local ethics, the investigators have applied for exemption from written informed consent.
Patients with psoriasis in the Department of Dermatology, Xijing Hospital of Air Force Medical University from December 2012 to December 2022 were consecutively collected. Inclusion criteria: (1) age ≥18 years; (2) Clear diagnosis of psoriasis. Exclusion criteria: (1) age <18; (2) Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases; (3) Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases.
The study collected various parameters, including baseline information such as ID number, gender, date of birth, medical history, and family history. Psoriasis-related data included age at first onset, date of diagnosis, duration of disease, frequency of relapse, psoriasis subtype, history of systemic/local medication, and comorbidities such as hypertension and dyslipidemia.
Furthermore, clinical examination data and laboratory tests were conducted, which included measurements such as height, weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), PASI score (Psoriasis Area and Severity Index), fasting plasma glucose (FPG), total cholesterol (TC), total triglycerides, uric acid, neutrophil count (normal range 1.80-6.30 × 109/L), and lymphocyte count (normal range 1.00-4.80 × 109/L). It is important to note that all blood tests were conducted prior to any treatment.
The above information was obtained from the Medical Record System of Xijing Hospital of Air Force Medical University.
- Conditions
- Psoriasis
- Keywords
- Hypertension, Antihypertensive Medication, Psoriasis
- Medical subject headings
- Psoriasis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| psoriasis patients | Patients with psoriasis in the Department of Dermatology, Xijing Hospital of Air Force Medical University from December 2012 to December 2022 were consecutively collected. Inclusion criteria: (1) age ≥18 years; (2) Clear diagnosis of psoriasis. Exclusion criteria: (1) age <18; (2) Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases; (3) Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases. | |
| Healthy individuals | Healthy individuals being randomly selected healthy individuals from a medical examination center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension as a risk factor for psoriasis
Hypertension has the potential to act as an underlying risk factor for the onset of psoriasis and has been identified as correlating with the frequency of recurrent psoriatic episodes.
Measured: Information collection: over a span of 2 months
Secondary outcomes (1)
Antihypertensive Medication as a risk factor for psoriasis
The use of antihypertensive medication may serve as a contributing factor to the risk of psoriatic relapse.
Measured: Information collection: over a span of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 9,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075394
- Sponsor's protocol ID
- xijingH-PF-202310
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antihypertensive Medication Usage on the Status of Psoriasis in Patients Concurrently Having Hypertension.
- ClinicalTrials.gov ID
- NCT06075394
- Acronym / sponsor ID
- xijingH-PF-202310
- Conditions
- Psoriasis
- Keywords
- Hypertension, Antihypertensive Medication, Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,294 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 10 Oct 2023 (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 influences of hypertension and antihypertensive medication on psoriasis have been long discussed. Given the limited and inconsistent evidence available, there is a need to further explore and clarify the relationship between hypertension and psoriasis, as well as to assess the relationship between antihypertensive medication use and the development or worsening of psoriasis symptoms. The aim of this retrospective study was to analyze data from electronic health records in a large population-based cohort, and the investigators aimed to investigate whether there was a significant association between hypertension and the use of related antihypertensive medications, such as ACEis, and psoriasis, and to explore potential confounders that may influence this association. Understanding the potential relationship between antihypertensive medication and psoriasis is critical, as this may have implications for the management of hypertension in patients with psoriasis or those at risk of developing the condition. This study will contribute to the existing body of evidence and provide valuable insights for clinicians to make informed decisions about the use of antihypertensive medication in this patient population, ultimately contributing to more effective prevention and management strategies for individuals affected by these diseases.
Detailed description
The investigators conducted a retrospective cohort study of psoriasis patients (≥18 years old) admitted as inpatients of Xijing hospital. Prior to the commencement of the survey, the investigators underwent collective training on data collection procedures to ensure the quality and reliability of the data. The study population included psoriasis patients aged 18 years or older who had been hospitalized at least once between 2012 and December 2022. Healthy individuals being randomly selected healthy individuals from a medical examination center. According to local ethics, the investigators have applied for exemption from written informed consent.
Patients with psoriasis in the Department of Dermatology, Xijing Hospital of Air Force Medical University from December 2012 to December 2022 were consecutively collected. Inclusion criteria: (1) age ≥18 years; (2) Clear diagnosis of psoriasis. Exclusion criteria: (1) age <18; (2) Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases; (3) Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases.
The study collected various parameters, including baseline information such as ID number, gender, date of birth, medical history, and family history. Psoriasis-related data included age at first onset, date of diagnosis, duration of disease, frequency of relapse, psoriasis subtype, history of systemic/local medication, and comorbidities such as hypertension and dyslipidemia.
Furthermore, clinical examination data and laboratory tests were conducted, which included measurements such as height, weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), PASI score (Psoriasis Area and Severity Index), fasting plasma glucose (FPG), total cholesterol (TC), total triglycerides, uric acid, neutrophil count (normal range 1.80-6.30 × 109/L), and lymphocyte count (normal range 1.00-4.80 × 109/L). It is important to note that all blood tests were conducted prior to any treatment.
The above information was obtained from the Medical Record System of Xijing Hospital of Air Force Medical University.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriasis patients | – | –Patients with psoriasis in the Department of Dermatology, Xijing Hospital of Air Force Medical University from December 2012 to December 2022 were consecutively collected. Inclusion criteria: (1) age ≥18 years; (2) Clear diagnosis of psoriasis. Exclusion criteria: (1) age <18; (2) Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases; (3) Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases. |
| Healthy individuals | – | –Healthy individuals being randomly selected healthy individuals from a medical examination center. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators conducted a retrospective cohort study of psoriasis patients (≥18 years old) admitted as inpatients of Xijing hospital. Prior to the commencement of the survey, the investigators underwent collective training on data collection procedures to ensure the quality and reliability of the data. The study population included psoriasis patients aged 18 years or older who had been hospitalized at least once between 2012 and December 2022. Healthy individuals being randomly selected healthy individuals from a medical examination center.
Key inclusion criteria (2 listed)
- Age ≥18 years;
- Clear diagnosis of psoriasis
Key exclusion criteria (3 listed)
- Age <18;
- Hypertension caused by conditions such as primary hypertension, hyperthyroidism, chronic renal insufficiency, or Cushing's syndrome, which are severe endocrine system diseases;
- Patients with autoimmune diseases, severe cardiovascular, hepatic, renal, or other major organ disorders, as well as blood disorders and endocrine system diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension as a risk factor for psoriasis
Time frame: Information collection: over a span of 2 months
Hypertension has the potential to act as an underlying risk factor for the onset of psoriasis and has been identified as correlating with the frequency of recurrent psoriatic episodes.
1 secondary outcome
Antihypertensive Medication as a risk factor for psoriasis
Time frame: Information collection: over a span of 2 months
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 12 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Xijing Hospital at 1 site in China.
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 2 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Hypertension as a risk factor for psoriasis (time frame: Information collection: over a span of 2 months). 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 12 Oct 2023.