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

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT02068937
Collaborator
(none)
206
Enrollment
1
Location
2
Arms
55
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
206 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

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
This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
Other Names:
  • Control Group

    		•
    Experimental: Furosemide and Phone contact

    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
    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)
    Other Names:
  • phone calls

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035 903

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Eneida R Rabelo da Silva, ScD, HCPA and UFRGS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT02068937
    Other Study ID Numbers:
    • GPPG/HCPA 10-0376
    First Posted:
    Feb 21, 2014
    Last Update Posted:
    Apr 22, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Hospital de Clinicas de Porto Alegre
    Heart Failure
    Therapy
    Diuretics
    Algorithms
    Additional relevant MeSH terms:
    Heart Failure
    Furosemide

    Study Results

    No Results Posted as of Apr 22, 2020