Fluid Restriction in Patients With Heart Failure

NCT04611594 | Unknown

• 1 other identifier: HCPA 2019-0216
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pulmonary ultrasound; Fluid restriction; Water restriction; Congestion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pulmonary ultrasound

  30 days

• Body weight

  30 days

• Major cardiovascular and non-cardiovascular clinical events

  30 days

• Multidisciplinary clinical events related to heart failure

  30 days

Study Arms (2)

Fluid restriction

EXPERIMENTAL

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

Behavioral: Fluid restriction

Control

NO INTERVENTION

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

Interventions

Fluid restriction BEHAVIORAL

Ingestion of approximately 20 ml / kg of ideal weight,

Fluid restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marcelo Nicola Branchi

CONTACT

+555499119187; mnbranchi@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduated Program of Federal University Program

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: November 2, 2020
• Study Start: February 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

BR (1)