NCT06090591

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
86mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2023Jun 2033

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2033

Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

October 13, 2023

Last Update Submit

March 15, 2024

Conditions

Heart FailureArrhythmias, CardiacAtrial FibrillationAcute Coronary Syndrome

Keywords

chronic heart failureacute coronary syndromeSGLT-2 inhibitorsanticoagulantsatrial fibrillationNTproBNPcardiac implanted electronic deviceobservationl

Outcome Measures

Primary Outcomes (5)

  • cardiovascular death

    death due to cardiovascular etiology during long term follow-up

    10 years

  • freedom from atrial arrhythmias

    Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up

    10 years

  • Time to revascularization

    Time to revascularization during acute coronary syndrome

    10 years

  • Bleeding complications

    Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy

    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

    10 years

Study Arms (6)

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

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

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

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

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

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).

Interventions

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

Acute coronary syndrome - ACSCardiac implantable electronic device - CIEDHeart failure with SGLT2 inhibitor therapy included - HF-SGLT2Transcatheter aortic valve implantation - TAVIVenous thromboembolism - VTE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with different cardiology pathology and diseases including arrhythmias, heart failure, venousn thromboembolism, implanted with CIED

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubrava University Hospital

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Heart FailureArrhythmias, CardiacAtrial FibrillationAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular Diseases

Study Officials

  • Ivana Jurin, M.D.

    Dubrava University Hospital

    STUDY CHAIR

  • Irzal Hadzibegovic, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Nikola Pavlovic, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Marin Pavlov, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Mario Udovicic, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Danijel Unic, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Ana Jordan, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Tomislav Sipic, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Diana Rudan, M.D.

    Dubrava University Hospital

    PRINCIPAL INVESTIGATOR

  • Sime Manola, M.D.

    Dubrava University Hospital

    STUDY DIRECTOR

Central Study Contacts

Ivan Zeljkovic, M.D.

CONTACT

00385917823289kardio@kbd.hr

Ivana Jurin, M.D.

CONTACT

ivanajurin1912@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., Associate Professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

June 1, 2033

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)