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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Furosemide and Phone contact
* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.<br>* Other names: Control Group;|
| Experimental: Furosemide and Phone contact<br>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<br>* 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)<br>* Other names: phone calls;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Therapy, Diuretics, Algorithms