Clinical trial NCT06244693: SUbCONgestion in Heart Failure Registry
Official title: Description and Analysis of Congestion During Hospitalization for Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Congestion
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure aged 18 years or above that are admitted in emergency room or outpatient clinic for acute decompensation of new or known heart failure, excluding diagnostics that mimics heart failure. Everyone has to be discharge from Hospital Clínico Universidad de 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.

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.

Primary outcomes:
measure: Rehospitalization
timeFrame: One year from discharge
measure: All cause mortality
timeFrame: One year after discharge
Secondary outcomes:
measure: Cardiac death
timeFrame: One year after discharge
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Departamento Cardiovascular - Hospital Clínico Universidad de Chile
state: Metropolitan
Study officials:
affiliation: Departamento Cardiovascular - Hospital Clínico Universidad de Chile
name: Alfredo Parra, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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