Clinical trial NCT06090591: Cardiology Research Dubrava Prospective Registry
Official title: Cardiology Research Dubrava: Single Centre, Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Arrhythmias, Cardiac
Atrial Fibrillation
Acute Coronary Syndrome
Keywords: chronic heart failure
acute coronary syndrome
SGLT-2 inhibitors
anticoagulants
atrial fibrillation
NTproBNP
cardiac implanted electronic device
observationl
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with different cardiology pathology and diseases including arrhythmias, heart failure, venousn thromboembolism, implanted with CIED

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.

Eligibility criteria: 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

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Primary outcomes:
measure: cardiovascular death
timeFrame: 10 years
measure: freedom from atrial arrhythmias
timeFrame: 10 years
measure: Time to revascularization
timeFrame: 10 years
measure: Bleeding complications
timeFrame: 10 years
measure: Laboratory levels of NTproBNP
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Dubrava University Hospital
Study officials:
affiliation: Dubrava University Hospital
name: Ivana Jurin, M.D.
role: STUDY_CHAIR
affiliation: Dubrava University Hospital
name: Irzal Hadzibegovic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Nikola Pavlovic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Marin Pavlov, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Mario Udovicic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Danijel Unic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Ana Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Tomislav Sipic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Diana Rudan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dubrava University Hospital
name: Sime Manola, M.D.
role: STUDY_DIRECTOR
References: