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NCT Number: NCT06773611

Electronic Register on Advanced Heart Failure and Transplantation di Cuore

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

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Luciano Potena, MD

CONTACT

[email protected]

0512143725

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Hospitalization for cardiovascular cause

    Time frame: 5 years

    Hospitalization for cardiovascular cause

  2. Death

    Time frame: 5 years

    Death

Secondary outcomes

  1. Hospitalization for non-cardiovascular cause

    Time frame: 5 years

    Hospitalization for non-cardiovascular cause

  2. Implantation of medical device (including mechanical support)

    Time frame: 5 years

    Implantation of medical device (including mechanical support)

  3. Need for intravenous diuretic therapy

    Time frame: 5 years

    Need for intravenous diuretic therapy

  4. Need for hemodialysis event

    Time frame: 5 years

    Need for hemodialysis event

Study contacts

Contact information is provided by the study sponsor or research team.

Luciano Potena, MD

CONTACT

[email protected]

051-2143725

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Electronic Register on Advanced Heart Failure and Transplantation

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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