Heart FailureCaRDrNCT06090591
Cardiology Research Dubrava Prospective Registry
An observational study of Heart Failure and Arrhythmias, Cardiac, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Arrhythmias, Cardiac, Atrial Fibrillation
- What is being tested?
- SGLT-2 inh therapy, CIED implantation, thromboaspiration,
- How many people
- 3,000 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2023to Jun 2033
- How long will I take part?
- 10 Years
- 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 with different cardiology pathology and diseases including arrhythmias, heart failure, venousn thromboembolism, implanted with CIED
Inclusion Criteria: patients implanted with CIED, or with VTE, or with ACS or with TAVI -
Exclusion Criteria: non compliance, not undergoing follow-up at this center
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ivana Jurin, M.D. contact
Croatia1 site, 1 recruiting
- Recruiting
Dubrava University Hospital
Zagreb, 10000
Sime Manola, M.D., kardio@kbd.hr
About this study
Official title: Cardiology Research Dubrava: Single Centre, Prospective Registry
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.
Read the detailed description
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.
In this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, NTproBNP values after specific interventions (in.ex. TAVI implantation, SGLT2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.
- Being tested
- SGLT-2 inh therapy, CIED implantation, thromboaspiration,
- Keywords
- chronic heart failure, acute coronary syndrome, SGLT-2 inhibitors, anticoagulants, atrial fibrillation, NTproBNP, cardiac implanted electronic device, observationl
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Atrial Fibrillation, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inh therapy, CIED implantation, thromboaspiration,Other
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary syndrome - ACS | patients who were diagnosed with acute coronary syndrome: STEMI, non-STE ACS - NSTEMI and unstable angina, who underwent coronary angiography and were prescribed with optimal medicament therapy Receives: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration, | |
| Transcatheter aortic valve implantation - TAVI | patients with aortic stenosis who underwent transcatheter percotaneous implantation of the arteficial aortic valve Receives: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration, | |
| Venous thromboembolism - VTE | patients with pulmonary embolism and deep vein thrombosis, with a focus on those who underwent thromboaspiration due to high or medium-high risk pulmonary embolism Receives: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration, | |
| Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2 | patients with heart failure with reduced, mid-reduced and preserved systolic function who were prescribed with a SGLT-2 inhibitor therapy, and other optimal medicament therapy for HF Receives: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration, | |
| Cardiac implantable electronic device - CIED | patients who were implanted with a cardiac implantable electronic device: pacemaker, conduction system pacing device, cardioverter-defibrilator or cardiac resynchronization therapy with or without defibrilator option Receives: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration, | |
| Arrhythmias | patients who underwent electrophysiology study, including PVI for atrial fibrillation, as well as SVT ablations, and ventricular arrhythmia ablation (both premature ventriclar beats and ventricular tachycardia ablation in ischsmic and non-ischemic cardiomyopathy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular death
death due to cardiovascular etiology during long term follow-up
Measured: 10 years
freedom from atrial arrhythmias
Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up
Measured: 10 years
Time to revascularization
Time to revascularization during acute coronary syndrome
Measured: 10 years
Bleeding complications
Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy
Measured: 10 years
Laboratory levels of NTproBNP
Laboratory levels of NTproBNP in patients with AFib after PVI, in patients with HF prescribed with SGLT2 inhibitors, in patients with ACS after complete revasculariazation, in patients implanted with CIED
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2023
- Primary completionJan 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Zeljkovic, University Hospital Dubrava
- Investigators
- Ivana Jurin, M.D., Study chair, Dubrava University HospitalIrzal Hadzibegovic, M.D., Principal investigator, Dubrava University HospitalNikola Pavlovic, M.D., Principal investigator, Dubrava University HospitalMarin Pavlov, M.D., Principal investigator, Dubrava University HospitalMario Udovicic, M.D., Principal investigator, Dubrava University HospitalDanijel Unic, M.D., Principal investigator, Dubrava University HospitalAna Jordan, M.D., Principal investigator, Dubrava University HospitalTomislav Sipic, M.D., Principal investigator, Dubrava University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090591
- Sponsor's protocol ID
- DUH-012017
- Acronym
- CaRDr
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radic M, Jurin I, Rode F, Simunovic L, Kolundzic P, Hadzibegovic I, Manola S, Vitlov P, Ivanovic Mihajlovic V, Grizelj D, Falak H, Udovicic M, Letilovic T. Heart Failure Etiology and 6-Month Cardiorenal Recovery Patterns After Early In-Hospital SGLT2 Inhibitor Initiation in HFrEF: A Prospective Real-World Cohort. Medicina (Kaunas). 2026 May 24;62(6):1017. doi: 10.3390/medicina62061017.
PubMed 42356030
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiology Research Dubrava: Single Centre, Prospective Registry
- ClinicalTrials.gov ID
- NCT06090591
- Acronym / sponsor ID
- CaRDr / DUH-012017
- Keywords
- chronic heart failure, acute coronary syndrome, SGLT-2 inhibitors, anticoagulants, atrial fibrillation, NTproBNP, cardiac implanted electronic device, observationl
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 19 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.
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.
Detailed description
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.
In this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, NTproBNP values after specific interventions (in.ex. TAVI implantation, SGLT2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome - ACS | – | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,patients who were diagnosed with acute coronary syndrome: STEMI, non-STE ACS - NSTEMI and unstable angina, who underwent coronary angiography and were prescribed with optimal medicament therapy |
| Transcatheter aortic valve implantation - TAVI | – | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,patients with aortic stenosis who underwent transcatheter percotaneous implantation of the arteficial aortic valve |
| Venous thromboembolism - VTE | – | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,patients with pulmonary embolism and deep vein thrombosis, with a focus on those who underwent thromboaspiration due to high or medium-high risk pulmonary embolism |
| Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2 | – | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,patients with heart failure with reduced, mid-reduced and preserved systolic function who were prescribed with a SGLT-2 inhibitor therapy, and other optimal medicament therapy for HF |
| Cardiac implantable electronic device - CIED | – | Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,patients who were implanted with a cardiac implantable electronic device: pacemaker, conduction system pacing device, cardioverter-defibrilator or cardiac resynchronization therapy with or without defibrilator option |
| Arrhythmias | – | –patients who underwent electrophysiology study, including PVI for atrial fibrillation, as well as SVT ablations, and ventricular arrhythmia ablation (both premature ventriclar beats and ventricular tachycardia ablation in ischsmic and non-ischemic cardiomyopathy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with different cardiology pathology and diseases including arrhythmias, heart failure, venousn thromboembolism, implanted with CIED
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 |
|---|---|---|
| SGLT-2 inh therapy, CIED implantation, thromboaspiration,long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital | Other | Acute coronary syndrome - ACS, Cardiac implantable electronic device - CIED, Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2, Transcatheter aortic valve implantation - TAVI, Venous thromboembolism - VTE |
Primary outcome
cardiovascular death
Time frame: 10 years
death due to cardiovascular etiology during long term follow-up
freedom from atrial arrhythmias
Time frame: 10 years
Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up
Time to revascularization
Time frame: 10 years
Time to revascularization during acute coronary syndrome
Bleeding complications
Time frame: 10 years
Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy
Laboratory levels of NTproBNP
Time frame: 10 years
Laboratory levels of NTproBNP in patients with AFib after PVI, in patients with HF prescribed with SGLT2 inhibitors, in patients with ACS after complete revasculariazation, in patients implanted with CIED
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 19 Mar 2024.
- Derived from this study: PubMed 42356030Radic M, Jurin I, Rode F, Simunovic L, Kolundzic P, Hadzibegovic I, Manola S, Vitlov P, Ivanovic Mihajlovic V, Grizelj D, Falak H, Udovicic M, Letilovic T. Heart Failure Etiology and 6-Month Cardiorenal Recovery Patterns After Early In-Hospital SGLT2 Inhibitor Initiation in HFrEF: A Prospective Real-World Cohort. Medicina (Kaunas). 2026 May 24;62(6):1017. doi: 10.3390/medicina62061017.
- 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.
Ivana Jurin, M.D. contact
Ivana Jurin, M.D. study chair
Dubrava University Hospital
Irzal Hadzibegovic, M.D. principal investigator
Dubrava University Hospital
Nikola Pavlovic, M.D. principal investigator
Dubrava University Hospital
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 Heart Failure and Arrhythmias, Cardiac, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Mar 2024. 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 Croatia. 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 Ivan Zeljkovic, M.D. (00385917823289, kardio@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular death (time frame: 10 years). The study lists 5 primary outcomes in all. 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 NCT06090591, which also lists 1 linked publication.
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 19 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.