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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04611594
Other study ID # HCPA 2019-0216
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date June 1, 2021

Study information

Verified date October 2020
Source Hospital de Clinicas de Porto Alegre
Contact Marcelo Nicola Branchi
Phone +555499119187
Email mnbranchi@hcpa.edu.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date June 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Fluid restriction
Ingestion of approximately 20 ml / kg of ideal weight,

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Body weight Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after) 30 days
Secondary Major cardiovascular and non-cardiovascular clinical events Hospital admissions and death 30 days
Secondary Multidisciplinary clinical events related to heart failure Six minutes walk test 30 days
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