Cardiology Research Dubrava Prospective Registry

Heart Failure Clinical Trial

— CaRDr  

Official title:

Cardiology Research Dubrava: Single Centre, Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090591
• Other study ID #: DUH-012017
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 2033

Study information

• Verified date: March 2024
• Source: University Hospital Dubrava
• Contact: Ivan Zeljkovic, M.D.
• Phone: 00385917823289
• Email: kardio[@]kbd.hr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2033
• Est. primary completion date: January 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Heart Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
Croatia	Dubrava University Hospital	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular death	death due to cardiovascular etiology during long term follow-up	10 years
Primary	freedom from atrial arrhythmias	Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up	10 years
Primary	Time to revascularization	Time to revascularization during acute coronary syndrome	10 years
Primary	Bleeding complications	Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy	10 years
Primary	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