CClinicalTrials.gg
Status unknownNCT03512782CARDIOENFUpdated Sep 5, 2018

Post-discharge Monitoring of Patients With Heart Failure

An interventional study of CARDIOENF in Heart Failure, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

What is proposed in this project is to develop and evaluate the effectiveness of an online remote monitoring system that is easily accessible to patients so that professionals with experience in monitoring patients with heart failure (HF) can monitor signs and symptoms of decompensation of the disease, as well as self-care actions. A randomized, blind trial for outcome evaluation was designed that will include patients hospitalized for acute HF at a referral institution in cardiology in southern Brazil. Patients in the intervention group will be followed up with a remote monitoring system, accessible by device (computer, tablet and cell phone) connected to the internet, by checking for signs, symptoms and self-care actions in three moments during 30 days after hospital discharge. Patients in the control group will follow up according to the routine of the hospital or physician assistant. The primary endpoint for assessing the efficacy of the system will be hospital readmission within 30 days (follow-up period). The information regarding the signs, symptoms and self-care of the patients will be monitored by the research team through an access schedule. The sample calculation points to the need to include a total of 142 patients (71 in each group). The data will be analyzed through descriptive and analytical statistics. It is hoped that the development of a remote monitoring system could be characterized as a strategy for the early detection of signs and symptoms of acute decompensation in HF patients, impacting on hospital readmission rates within 30 days after discharge. In addition, remote monitoring of signs and symptoms may promote improved adherence and self-care of patients. The scientific contribution will occur to the extent to which there is innovation in patient follow-up and feedback obtained from the patient's interaction with the system.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 142 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • with diagnosis of HF or hospitalized for acute HF

Exclusion criteria

Exclusion Criteria:

  • degenerative neurological diseases;
  • patients with renal / hepatic / pulmonary or systemic disease that may confuse the interpretation of findings or result in limited life expectancy;
  • surgical or therapeutic plan that may influence the follow-up;
  • pregnancy;
  • diagnosis of acute HF secondary to: sepsis, myocarditis, acute myocardial infarction, peripartum and other acute cause;
  • not be able to contact by phone.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
142 participants (estimated)

Study arms

  • No intervention
    CONTROL
  • Experimental
    INTERVENTION

    Other: CARDIOENF

Interventions

  • OtherCARDIOENF

    The patients listed in interventional group will have access to software Cardioenf that is a app used in a device (cel phone, tablet) to monitoring signs and symptoms of the heart failure patients after discharge from hospital. In this software, their signs and symptoms will be inserted in three moments during the first 30 days after discharge. Nurses will monitor these data in the follow-up period.

06

What researchers measure

Primary outcomes

  1. hospital readmission

    admission to the emergency department or hospitalization

    Time frame: 1 month

Secondary outcomes

  1. signs and symptoms of decompensation of heart failure

    Time frame: 1 month

07

Study locations

1 site
  • Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
    Porto Alegre, Rio Grande Do Sul 90050-170, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03512782
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Irmandade Santa Casa de Misericórdia de Porto Alegre
Responsible party
Sponsor
First posted
May 1, 2018
Start date
Sep 1, 2018 (estimated)
Primary completion
Mar 30, 2019 (estimated)
Completion
Apr 30, 2019 (estimated)
Last update
Sep 5, 2018

Study contacts

Emiliane Souza, PhD
Contact
enogsouza@gmail.com
555133038858
Emiliane Souza, PhD
Contact
emilianes@ufcspa.edu.br

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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