Fluid Restriction in Patients With Heart Failure

NCT ID: NCT04611594

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-06-01

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.

Conditions

Heart Failure, Systolic; Heart Failure; With Decompensation; Pulmonary Congestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fluid restriction

Prescription to ingest approximately 20 ml / kg of ideal weight.

Group Type: EXPERIMENTAL

Fluid restriction

Intervention Type: BEHAVIORAL

Ingestion of approximately 20 ml / kg of ideal weight,

Control

Prescription to ingest approximately 30 ml / kg of ideal weight, considered a normal amount of daily water intake.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluid restriction

Ingestion of approximately 20 ml / kg of ideal weight,

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Luis Eduardo Paim Rohde

Post Graduated Program of Federal University Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marcelo Nicola Branchi

Role: CONTACT

mnbranchi@hcpa.edu.br

+555499119187

Facility Contacts

Marcelo Nicola Branchi

Role: primary

mnbranchi@hcpa.edu.br

+5554999118717

Other Identifiers

HCPA 2019-0216

Identifier Type: -

Identifier Source: org_study_id