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Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study
Maria Karolina Echer Ferreira Feijó1, Andreia Biolo2,3, Karen Brasil Ruschel4
1School of Nursing, Graduate Program Federal University of Rio Grande do Sul, São Manoel, 963 - Rio Branco, Porto Alegre, RS, 90620-110, Brazil. mariakarolinafeijo@gmail.com.
Insights
This study will assess the Algoritmo de Ajuste de Diurético (AAD) and non-pharmacologic management to improve heart failure (HF) clinical stability and reduce 90-day hospital readmissions. The AAD aims to optimize diuretic dosage for better HF patient outcomes.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Heart failure (HF) management faces challenges in achieving clinical stability and reducing hospital readmissions.
- The Diuretic Treatment Algorithm (DTA), validated in Brazil as the Algoritmo de Ajuste de Diurético (AAD), is feasible but its clinical outcome impact is unassessed.
- A randomized trial protocol is described to evaluate the AAD's effectiveness in improving HF patient outcomes.
Purpose of the Study:
- To assess the effectiveness of the AAD algorithm combined with non-pharmacologic management.
- To improve clinical stability in patients with heart failure.
- To reduce the 90-day hospital readmission rate in heart failure patients.
Main Methods:
- Prospective randomized open blinded endpoint (PROBE) parallel-group trial design.
- Adult patients with reduced ejection fraction HF recruited from a specialized HF clinic.
- Intervention group: AAD for diuretic adjustment and weekly calls for non-pharmacologic management reinforcement; Control group: standard physician adjustment and no calls.
- Study endpoints: 90-day readmission/emergency department visits for HF decompensation and clinical instability.
Main Results:
- The trial is designed to assess the effectiveness of the AAD and non-pharmacologic management.
- The study aims to identify early signs of clinical deterioration.
- The combined intervention seeks to reduce emergency department visits and readmission rates.
Conclusions:
- This trial will evaluate the combined impact of the AAD algorithm and non-pharmacologic strategies.
- The study will determine the efficacy of this intervention in managing heart failure decompensation.
- Outcomes will focus on reducing emergency care utilization and hospital readmissions.
Background:
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.
Methods/Design:
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.
Discussion:
This trial shall assess the effectiveness of the AAD algorithm and non-pharmacologic management by early identification of clinical deterioration and establishment of a combined intervention to reduce emergency department visits, readmission rate, or a composite endpoint thereof.
Trial Registration Number:
ClinicalTrials.gov Identifier, NCT02068937 (23 February 2014).
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