SUbCONgestion in Heart Failure Registry

NCT ID: NCT06244693

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-02-01

Brief Summary

The goal of this observational study is to learn about the decongestion process in heart failure patients. The main question it aims to answer is: What is the behavior of congestion during hospitalization in adult patients with acute heart failure (AHF)? Participants will be evaluated in the decongestion process through clinical, analytical, and ultrasonographic variables, and they will be followed up for one year to assess mortality and rehospitalization rates in this population.

Detailed Description

Heart failure (HF) is a syndrome characterized by the presence of dyspnea, lower extremity edema, orthopnea, jugular venous distention, and pulmonary crackles, among others, secondary to elevated ventricular filling pressures. It is the leading cause of hospitalization in medical services in Chile and worldwide, with the majority of patients being elderly. Decompensation of HF is explained in most cases by fluid overload (congestion) and can be studied through biomarkers, clinical signs, radiographic, and ultrasonographic findings. The Chilean demographic transition makes it necessary to optimize the multiparametric and protocolized management of hospitalized patients.

General Objective: To evaluate and describe the decongestion process, including residual congestion, during hospitalization for heart failure at the Clinical Hospital of the University of Chile (HCUCh).

A prospective observational cohort study will be conducted with all patients hospitalized for heart failure at HCUCh. Clinical, analytical, and ultrasonographic variables, especially those related to congestion assessment, will be recorded. Enrollment will last for one year from institutional authorization, and telephone follow-up will be conducted for one year post-discharge, extendable up to five year.

Conditions

Heart Failure; Congestion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults diagnosed with decompensated heart failure in the emergency department or cardiology outpatient clinic at the Clinical Hospital of the University of Chile (HCUCh).
• Profile of warm-wet and cold-wet type heart failure.
• Spontaneous ventilation with or without non-invasive mechanical support.
• Desire for participation validated through informed consent.

Exclusion Criteria

• Dry-type heart failure profile (warm and cold)
• Diagnostics that mimics heart failure (valvular heart disease, cardiomyopathies, and others diagnostic different from heart failure).
• Septic, distributive, or obstructive shock
• Polytraumatized
• Severe burns
• Invasive mechanical ventilation
• Permanent renal replacement therapy
• Severe dependence
• Presence of terminal illness with a prognosis of survival less than one year
• Presence of traumatic conditions that prevent the use of thoracic ultrasound, such as a flail chest or moderate to severe burn on the left hemithorax.
• Lack of a support network or contact.
• Cardiorespiratory arrest
• Refusal to participate as indicated in the informed consent.
• Presence of psychological or intellectual disability that prevents expressing the will to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo Parra, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Departamento Cardiovascular - Hospital Clínico Universidad de Chile

Locations

Departamento Cardiovascular - Hospital Clínico Universidad de Chile

Santiago, Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Alfredo Parra, MD, PhD

Role: CONTACT

alfredop@uchile.cl

229788326 ext. 56

Manuel Mallol, MD, MSc

Role: CONTACT

manuel.mallol@gmail.com

229789235 ext. 56

Facility Contacts

Alfredo Parra, MD, PhD

Role: primary

cardiovascular@hcuch.cl

229788000 ext. 56

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Study Documents

Document Type: Individual Participant Data Set

Data registry online system provided by sponsor

View Document

Other Identifiers

01-2024

Identifier Type: -

Identifier Source: org_study_id