Valvular DiseaseBIA-WADNCT04527367
Epidemiology and Long-term Outcome of Patients With VHD
An observational study of Valvular Disease and Valvular Heart Disease, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Disease, Valvular Heart Disease, Aortic Valve Stenosis
- What is being tested?
- Innovative medical technologies in invasive cardiology and cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2006to Jan 2022
- 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: Patients hospitalized in Medical University of Bialystok.
Who may be able to join
- Valvular heart disease in moderate and severe stages
Who cannot join
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Bialystok, 15-276
About this study
Official title: Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.
Read the detailed description
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.
Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment
- Conditions
- Valvular Disease, Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency and Aortic Stenosis, Mitral Stenosis, Coronary Artery Disease
- Being tested
- Innovative medical technologies in invasive cardiology and cardiac surgery
- Keywords
- Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency, Coronary Artery Disease, Chronic Kidney Diseases
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Coronary Artery Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative medical technologies in invasive cardiology and cardiac surgeryProcedure or surgery
Also called Percutaneous coronary intervention, Percutaneous aortic valve replacement, Percutaneous interventional mitral regurgitation treatment, Cardiosurgery
A follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed.
| Study group | Role | What they receive |
|---|---|---|
| VHD patients | Patients with moderate and severe valvular heart diseases Receives: Procedure: Innovative medical technologies in invasive cardiology and cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All-cause of mortality
Measured: 3665 days
Secondary outcomes (1)
MACCE
Mocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization
Measured: 3665 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study startJan 2006
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Valvular DiseaseStudies 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
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Kuzma, Medical University of Bialystok
- Investigators
- Łukasz Kuźma, MD, PhD, Principal investigator, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527367
- Sponsor's protocol ID
- UMB-KKI-101
- Acronym
- BIA-WAD
- Status last verified
- Dec 2021
- First submitted
- 22 Aug 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuzma L, Bachorzewska-Gajewska H, Kozuch M, Struniawski K, Pogorzelski S, Hirnle T, Dobrzycki S. Acute coronary syndromes and atherosclerotic plaque burden distribution in coronary arteries among patients with valvular heart disease (BIA-WAD registry). Postepy Kardiol Interwencyjnej. 2019;15(4):422-430. doi: 10.5114/aic.2019.90216. Epub 2019 Dec 8.
PubMed 31933658Kuzma L, Malyszko J, Bachorzewska-Gajewska H, Niwinska MM, Kurasz A, Zalewska-Adamiec M, Kozuch M, Dobrzycki S. Impact of chronic kidney disease on long-term outcome of patients with valvular heart defects. Int Urol Nephrol. 2020 Nov;52(11):2161-2170. doi: 10.1007/s11255-020-02561-4. Epub 2020 Jul 14.
PubMed 32661631
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)
- ClinicalTrials.gov ID
- NCT04527367
- Acronym / sponsor ID
- BIA-WAD / UMB-KKI-101
- Conditions
- Valvular Disease, Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency and Aortic Stenosis, Mitral Stenosis, Coronary Artery Disease
- Keywords
- Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency, Coronary Artery Disease, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 26 Aug 2020 (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.
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.
Detailed description
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.
Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VHD patients | – | Procedure: Innovative medical technologies in invasive cardiology and cardiac surgeryPatients with moderate and severe valvular heart diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Medical University of Bialystok.
Key inclusion criteria (1 listed)
- Valvular heart disease in moderate and severe stages
Key exclusion criteria (1 listed)
- Age < 18 years old
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 |
|---|---|---|
| Innovative medical technologies in invasive cardiology and cardiac surgeryAlso: Percutaneous coronary intervention, Percutaneous aortic valve replacement, Percutaneous interventional mitral regurgitation treatment, CardiosurgeryA follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed. | Procedure or surgery | VHD patients |
Primary outcome
Death
Time frame: 3665 days
All-cause of mortality
1 secondary outcome
MACCE
Time frame: 3665 days
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 21 Jan 2022.
- Results publication: PubMed 31933658Kuzma L, Bachorzewska-Gajewska H, Kozuch M, Struniawski K, Pogorzelski S, Hirnle T, Dobrzycki S. Acute coronary syndromes and atherosclerotic plaque burden distribution in coronary arteries among patients with valvular heart disease (BIA-WAD registry). Postepy Kardiol Interwencyjnej. 2019;15(4):422-430. doi: 10.5114/aic.2019.90216. Epub 2019 Dec 8.
- Results publication: PubMed 32661631Kuzma L, Malyszko J, Bachorzewska-Gajewska H, Niwinska MM, Kurasz A, Zalewska-Adamiec M, Kozuch M, Dobrzycki S. Impact of chronic kidney disease on long-term outcome of patients with valvular heart defects. Int Urol Nephrol. 2020 Nov;52(11):2161-2170. doi: 10.1007/s11255-020-02561-4. Epub 2020 Jul 14.
- Individual participant dataSharing planned: No
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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.
Łukasz Kuźma, MD, PhD principal investigator
Medical University of Bialystok
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 Valvular Disease and Valvular Heart Disease, run by Medical University of Bialystok 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: finished, as of the sponsor's last update on 21 Jan 2022. 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?
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?
Death (time frame: 3665 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527367, which also lists 2 linked publications.
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 21 Jan 2022.