SUbCONgestion in Heart Failure Registry

Recruiting

• Conditions: Heart Failure; Congestion

• Registration Number: NCT06244693
• Lead Sponsor: University of Chile

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-04-01
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rehospitalization	One year from discharge	Readmission to hospital for cardiac cause
All cause mortality	One year after discharge	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Cardiac death	One year after discharge	Death form cardiac cause

Trial Locations

Locations (1)

Departamento Cardiovascular - Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitan, Chile