NCT06773611

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 4, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 14, 2025

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

Heart FailureHeart Transplantation

Outcome Measures

Primary Outcomes (2)

  • Hospitalization for cardiovascular cause

    Hospitalization for cardiovascular cause

    5 years

  • Death

    Death

    5 years

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Luciano G Potena, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Potena, MD

CONTACT

051-2143725scompenso.trapiantocuore@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 14, 2025

Study Start

September 4, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 14, 2025

Record last verified: 2024-12

Locations

IT(1)