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

NCT02068937 | Completed

• 1 other identifier: GPPG/HCPA 10-0376
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Therapy; Diuretics; Algorithms

Outcome Measures

Primary Outcomes (1)

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

  90 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Drug: Furosemide

Furosemide and Phone contact

EXPERIMENTAL

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.

Drug: Furosemide and Phone contact

Interventions

Furosemide and Phone contact DRUG

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)

Also known as: phone calls

Furosemide and Phone contact

Furosemide DRUG

This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.

Also known as: Control Group

Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035 903, Brazil

Location

Related Publications (2)

• 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.

  PMID: 33966521 DERIVED

• 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.

  PMID: 25885424 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eneida R Rabelo da Silva, ScD

  HCPA and UFRGS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 21, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

BR (1)