Cardiology Research Dubrava Prospective Registry

Recruiting

• Conditions: Heart Failure; Arrhythmias, Cardiac; Atrial Fibrillation; Acute Coronary Syndrome
• Interventions: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,

• Registration Number: NCT06090591
• Lead Sponsor: University Hospital Dubrava

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.

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 Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19
• Primary Completion: 2033-01
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute coronary syndrome - ACS	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	SGLT-2 inh therapy, CIED implantation, thromboaspiration,	patients with aortic stenosis who underwent transcatheter percotaneous implantation of the arteficial aortic valve
Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2	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	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
Venous thromboembolism - VTE	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

Primary Outcome Measures

Name	Time	Method
freedom from atrial arrhythmias	10 years	Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up
Laboratory levels of NTproBNP	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
cardiovascular death	10 years	death due to cardiovascular etiology during long term follow-up
Time to revascularization	10 years	Time to revascularization during acute coronary syndrome
Bleeding complications	10 years	Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy

Trial Locations

Locations (1)

Dubrava University Hospital; 🇭🇷 Zagreb, Croatia