Fluid Restriction in Patients With Heart Failure
Primary Purpose
Heart Failure, Systolic, Heart Failure; With Decompensation, Pulmonary Congestion
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fluid restriction
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Pulmonary ultrasound, Fluid restriction, Water restriction, Congestion
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.
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fluid restriction
Control
Arm Description
Prescription to ingest approximately 20 ml / kg of ideal weight.
Prescription to ingest approximately 30 ml / kg of ideal weight, considered a normal amount of daily water intake.
Outcomes
Primary Outcome Measures
N-terminal pro-BNP
Variation in plasma NT pro-BNP levels (from the day of hospital discharge to approximately 30 days after).
Secondary Outcome Measures
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).
Body weight
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
Hospital admissions and death
Multidisciplinary clinical events related to heart failure
Six minutes walk test
Full Information
NCT ID
NCT04611594
First Posted
September 15, 2020
Last Updated
October 27, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04611594
Brief Title
Fluid Restriction in Patients With Heart Failure
Official Title
Impact of Fluid Restriction in Patients With Pulmonary Congestion After Discharge From an Acute Decompensated Heart Failure Hospitalization: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Heart Failure; With Decompensation, Pulmonary Congestion
Keywords
Pulmonary ultrasound, Fluid restriction, Water restriction, Congestion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluid restriction
Arm Type
Experimental
Arm Description
Prescription to ingest approximately 20 ml / kg of ideal weight.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Prescription to ingest approximately 30 ml / kg of ideal weight, considered a normal amount of daily water intake.
Intervention Type
Behavioral
Intervention Name(s)
Fluid restriction
Intervention Description
Ingestion of approximately 20 ml / kg of ideal weight,
Primary Outcome Measure Information:
Title
N-terminal pro-BNP
Description
Variation in plasma NT pro-BNP levels (from the day of hospital discharge to approximately 30 days after).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pulmonary ultrasound
Description
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).
Time Frame
30 days
Title
Body weight
Description
Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after)
Time Frame
30 days
Title
Major cardiovascular and non-cardiovascular clinical events
Description
Hospital admissions and death
Time Frame
30 days
Title
Multidisciplinary clinical events related to heart failure
Description
Six minutes walk test
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Nicola Branchi
Phone
+555499119187
Email
mnbranchi@hcpa.edu.br
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Nicola Branchi
Phone
+5554999118717
Email
mnbranchi@hcpa.edu.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fluid Restriction in Patients With Heart Failure
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