Fluid Restriction in Patients With Heart Failure

Not Applicable

• Conditions: Pulmonary Congestion; Heart Failure, Systolic; Heart Failure; With Decompensation
• Interventions: Behavioral: Fluid restriction

• Registration Number: NCT04611594
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.

Detailed Description

The need for hospitalization is an important marker of poor prognosis in patients with heart failure. It is estimated that 25% of patients presenting with acute heart failure are readmitted within 30 days. The maintenance of signs and symptoms of congestion at hospital discharge are common causes of hospital readmission. Thus, the reduction of these signs is a goal to be reached during hospitalization so that the chances of readmission are reduced. However, there is evidence that approximately ¼ of the patients are released despite persisting signs of congestive symptoms. It seems plausible to speculate that patients with HF at higher risk of rehospitalization would be those with the greatest chance of benefiting from therapeutic strategies that seek to reduce the congestive state, such as fluid restriction. In this scenario of initial vulnerability after hospitalization for acutely decompensated HF, recent studies have demonstrated a correlation in the number of B lines in the pulmonary ultrasound of patients at the time of hospital discharge and the prediction of frequent clinical outcomes. It was observed that the presence of pattern B, defined as the presence of more than 3 B lines in at least 2 pulmonary fields bilaterally, was associated with a worse prognosis (mortality from all causes and hospitalization due to decompensation). The present study, therefore, will evaluate the effect of outpatient fluid restriction on levels of NT-proBNP in patients who remain with signs of congestion based on pulmonary ultrasound at the bedside during hospital discharge.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-09-15
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02
• Primary Completion: 2021-02-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Hospital admission for primary diagnosis of acutely decompensated heart failure, regardless of etiology, according to the criteria of the American College of Cardiology;
• Diagnosis on echocardiography of heart failure with reduced ejection fraction (<40%);
• Presence of pulmonary congestion defined as at least 2 pulmonary fields with more than 3 B lines in each field on pulmonary ultrasound at the time of hospital discharge.

Exclusion Criteria

• Pulmonary fibrosis or other severe disease that changes the image acquisition (significant pleural effusion, severe pulmonary emphysema, previous pneumectomy or lobectomy, primary or metastatic lung cancer, breast implants);
• Pregnancy;
• Dialysis renal failure patient;
• Factors that could hinder follow-up (not returning to the outpatient clinic of Hospital de Clínicas);
• Disability or refusing to understand and adhere to the protocol;
• Refusal to sign consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid restriction	Fluid restriction	Prescription to ingest approximately 20 ml / kg of ideal weight.

Primary Outcome Measures

Name	Time	Method
N-terminal pro-BNP	30 days	Variation in plasma NT pro-BNP levels (from the day of hospital discharge to approximately 30 days after).

Secondary Outcome Measures

Name	Time	Method
Pulmonary ultrasound	30 days	Variation in the total number of B lines in all lung fields measured by ultrasound (from the day of hospital discharge until approximately 30 days after).
Body weight	30 days	Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after)
Major cardiovascular and non-cardiovascular clinical events	30 days	Hospital admissions and death
Multidisciplinary clinical events related to heart failure	30 days	Six minutes walk test

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil