Fluid Restriction in Patients With Heart Failure

Impact of Fluid Restriction in Patients With Pulmonary Congestion After Discharge From an Acute Decompensated Heart Failure Hospitalization: a Randomized Clinical Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure, Systolic; Heart Failure; With Decompensation; Pulmonary Congestion
• Intervention / Treatment: Behavioral: Fluid restriction

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcelo Nicola Branchi; Phone Number: +555499119187; Email: mnbranchi@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Marcelo Nicola Branchi; Phone Number: +5554999118717; Email: mnbranchi@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fluid restriction; Prescription to ingest approximately 20 ml / kg of ideal weight.	Behavioral: Fluid restriction; Ingestion of approximately 20 ml / kg of ideal weight,
NO_INTERVENTION: Control; Prescription to ingest approximately 30 ml / kg of ideal weight, considered a normal amount of daily water intake.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary ultrasound	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).	30 days
Body weight	Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after)	30 days
Major cardiovascular and non-cardiovascular clinical events	Hospital admissions and death	30 days
Multidisciplinary clinical events related to heart failure	Six minutes walk test	30 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Fluid restriction; Congestion; Pulmonary ultrasound; Water restriction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: HCPA 2019-0216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No