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Clinical Trials/NCT06773611
NCT06773611
Recruiting
Not Applicable

Electronic Register on Advanced Heart Failure and Transplantation

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country10,000 target enrollmentSeptember 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
10000
Locations
1
Primary Endpoint
Hospitalization for cardiovascular cause
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to create an electronic registry of patients diagnosed with Advanced Heart Failure or Heart Transplant, starting from 01/01/1985 and to assess the incidence of Advanced Heart Failure and Heart Transplant, and characterize patients affected by the first or undergoing the second procedure, starting from 01/01/1985. The primary outcomes are:

  • Hospitalization for cardiovascular cause
  • Death

Detailed Description

Heart failure is a pathological condition characterized by high morbidity and mortality, and it leads to a significant worsening of the quality of life for patients. The treatment of heart failure involves various options; the goal is to slow down the progression of the disease, reduce hospitalizations, increase survival, and reduce symptoms in order to improve the quality of life. Treatments range from pharmacological therapy to lifestyle changes, from device implantation to heart transplant surgery. Early diagnosis and treatment often help reduce symptoms, and many patients with heart failure can return to an active life. Patients with heart failure must undergo regular check-ups to assess their general physical condition and the status of the disease. It is therefore essential to evaluate and systematize the different therapies. This study is both retrospective and prospective

Registry
clinicaltrials.gov
Start Date
September 4, 2023
End Date
September 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Ability to provide informed consent
  • Diagnosis of Advanced Heart Failure or Heart Transplant

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hospitalization for cardiovascular cause

Time Frame: 5 years

Hospitalization for cardiovascular cause

Death

Time Frame: 5 years

Death

Secondary Outcomes

  • Hospitalization for non-cardiovascular cause(5 years)
  • Implantation of medical device (including mechanical support)(5 years)
  • Need for intravenous diuretic therapy(5 years)
  • Need for hemodialysis event(5 years)

Study Sites (1)

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