HypercholesterolemiaNCT06858982
PMMHRI-Pitavastatin Registry
An observational study of Hypercholesterolemia, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial summary
The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics who is taking pitavastatin.
Who may be able to join
- patient takling pitavastatin based on the 2021 Polish Lipid Guidelines
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Polish Mother's Memorial Hospital Research Institute
Lodz, 93-338
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA, +48 42 2711599, maciej.banach@icloud.com
About this study
Official title: The Polish Mother's Memorial Hospital Research Institute Pitavastatin Registry
The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.
Read the detailed description
The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI), the second-largest supra-regional hospital in Poland. The registry was initiated in January 2024 to systematically collect real-world data on patients prescribed pitavastatin, aiming to assess its effectiveness, safety, and impact on lipid and cardiovascular risk management.
The registry has included all patients from the Departments of Cardiology and Endocrinology, as well as outpatient cardiology and endocrinology clinics, who have been prescribed pitavastatin. The inclusion of a broad patient population allows for a comprehensive evaluation of treatment patterns and outcomes in routine clinical practice.
Patient data are extracted from electronic medical records and include:
Demographic parameters (age, sex, BMI, etc.) Relevant comorbidities (e.g., hypertension, diabetes, chronic kidney disease) Concomitant medications, including: Lipid-lowering therapy status (monotherapy vs. combination therapy), Anticoagulation status Lifestyle factors, such as smoking status Post hoc calculated cardiovascular risk scores, to stratify patients based on their predicted risk of major adverse cardiovascular events (MACE) Laboratory parameters, including lipid profiles, inflammatory markers, and metabolic indicators.
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, pitavastatin
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's characteristic.
Characteristic of patients treated with pitavastatin among the Polish population.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jun 2024
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858982
- Sponsor's protocol ID
- PMMHRI-Pitavastatin Registry
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Polish Mother's Memorial Hospital Research Institute Pitavastatin Registry
- ClinicalTrials.gov ID
- NCT06858982
- Acronym / sponsor ID
- PMMHRI-Pitavastatin Registry
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, pitavastatin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Mar 2025 (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 PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.
Detailed description
The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI), the second-largest supra-regional hospital in Poland. The registry was initiated in January 2024 to systematically collect real-world data on patients prescribed pitavastatin, aiming to assess its effectiveness, safety, and impact on lipid and cardiovascular risk management.
The registry has included all patients from the Departments of Cardiology and Endocrinology, as well as outpatient cardiology and endocrinology clinics, who have been prescribed pitavastatin. The inclusion of a broad patient population allows for a comprehensive evaluation of treatment patterns and outcomes in routine clinical practice.
Patient data are extracted from electronic medical records and include:
Demographic parameters (age, sex, BMI, etc.) Relevant comorbidities (e.g., hypertension, diabetes, chronic kidney disease) Concomitant medications, including: Lipid-lowering therapy status (monotherapy vs. combination therapy), Anticoagulation status Lifestyle factors, such as smoking status Post hoc calculated cardiovascular risk scores, to stratify patients based on their predicted risk of major adverse cardiovascular events (MACE) Laboratory parameters, including lipid profiles, inflammatory markers, and metabolic indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics who is taking pitavastatin.
Key inclusion criteria (1 listed)
- patient takling pitavastatin based on the 2021 Polish Lipid Guidelines
Key exclusion criteria (1 listed)
- -
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
Patient's characteristic.
Time frame: 5 years
Characteristic of patients treated with pitavastatin among the Polish population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
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 Hypercholesterolemia, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maciej Banach, MD,PhD, FNLA, FAHA,FESC, FASA (+48 42 2711599, maciej.banach@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's characteristic. (time frame: 5 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 5 Mar 2025.