Electronic Register on Advanced Heart Failure and Transplantation di Cuore

Electronic Register on Advanced Heart Failure and Transplantation

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Transplantation

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

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Luciano Potena, MD; Phone Number: 051-2143725; Email: scompenso.trapiantocuore@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Luciano Potena, MD; Phone Number: 0512143725; Email: scompenso.trapiantocuore@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients attending the SSD Heart Failure and Transplants unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna will be evaluated, starting from 01/01/1985. Each patient has been and will be followed according to standard care practices.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization for cardiovascular cause	Hospitalization for cardiovascular cause	5 years
Death	Death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization for non-cardiovascular cause	Hospitalization for non-cardiovascular cause	5 years
Implantation of medical device (including mechanical support)	Implantation of medical device (including mechanical support)	5 years
Need for intravenous diuretic therapy	Need for intravenous diuretic therapy	5 years
Need for hemodialysis event	Need for hemodialysis event	5 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Luciano G Potena, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Rescat

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No