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Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Furosemide and Phone contact
Furosemide
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Therapy, Diuretics, Algorithms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both genders
  • Age ≥ 18 years
  • Diagnosed with systolic HF
  • Able to monitor body weight at home
  • Using furosemide

Exclusion Criteria:

  • Those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Furosemide and Phone contact

Arm Description

In the control group, patients just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline. The patients do not receive phone calls neither advising on non-pharmacological treatment; The medication is adjusted by the doctor during the initial evaluation of study baseline.

The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day.

Outcomes

Primary Outcome Measures

Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2014
Last Updated
April 20, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02068937
Brief Title
Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients
Official Title
Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF.
Detailed Description
A PROBE (prospective randomized open blinded endpoint) parallel-group design will be used. Adult patients with a diagnosis of reduced ejection fraction HF, who are being treated at a specialized HF clinic are being recruited. Those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial. Participants in the intervention group (IG) shall have their diuretic doses adjusted in accordance with the AAD and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction). Participants in the control group (CG) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls. Patients in both groups shall return at 1 month for face-to-face reassessment. The study endpoints shall comprise readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. All participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit. Overall, 135 patients are expected to be enrolled in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Therapy, Diuretics, Algorithms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
In the control group, patients just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline. The patients do not receive phone calls neither advising on non-pharmacological treatment; The medication is adjusted by the doctor during the initial evaluation of study baseline.
Arm Title
Furosemide and Phone contact
Arm Type
Experimental
Arm Description
The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day.
Intervention Type
Drug
Intervention Name(s)
Furosemide and Phone contact
Other Intervention Name(s)
phone calls
Intervention Description
The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day (1 tablet equivalent to 40 milligrams of furosemide)
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Control Group
Intervention Description
This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
Primary Outcome Measure Information:
Title
Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both genders Age ≥ 18 years Diagnosed with systolic HF Able to monitor body weight at home Using furosemide Exclusion Criteria: Those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo da Silva, ScD
Organizational Affiliation
HCPA and UFRGS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035 903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33966521
Citation
Feijo MK, Ruschel KB, Bernardes D, Ferro EB, Rohde LE, Biolo A, Rabelo da Silva ER. Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):288-297. doi: 10.1177/1357633X211009640. Epub 2021 May 9.
Results Reference
derived
PubMed Identifier
25885424
Citation
Feijo MK, Biolo A, Ruschel KB, Orlandin L, Aliti GB, Rabelo-Silva ER. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:44. doi: 10.1186/s13063-015-0559-7.
Results Reference
derived

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Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients

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