Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

December 7, 2022 updated by: Hospital Italiano de Buenos Aires

Clinical Trial on Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure. Follow-up period 1 month.

This protocol aims through a multidisciplinary vision, to carry out during hospitalization a comprehensive geriatric evaluation that allows to know the medical and socio-environmental needs of the patient to plan the required care at home and achieve an effective transition.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • C.a.b.a
      • Buenos Aires, C.a.b.a, Argentina, C1199
        • Rodrigo Aguirre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 65 years or older
  2. Decompensated heart failure
  3. FRAIL scale equal to 3 or more points
  4. Permanent residence in the Metropolitan Area of Buenos Aires

Exclusion Criteria:

  1. Refusal to participate in the study
  2. Terminal oncology or cardiological disease
  3. Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis)
  4. Patients followed by geriatrics prior to admission
  5. Simultaneous participation in another research protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Management Program
Comanagement program (cardiological-geriatric) to carry out during hospitalization a comprehensive evaluation that allows to know the medical and socio-environmental needs of the patients to plan the required care at home and achieve an effective transition.
Other: Management Program
Joint management between the geriatric and cardiology team of the geriatric syndromes and heart failure. Education of the patient and their caregiver, preparing them for the transition of care.
No Intervention: Usual Care
Usual care during hospitalizacion and discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital admission
Time Frame: 30 days
Number of hospital admission for any cause within 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Number of deaths from any cause within 30 days
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of fragility
Time Frame: Admission
The proportion of patients with a FRAIL scale equal to 3 or more points of the total number of patients hospitalized for heart failure
Admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: César Belziti, MD, Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

November 9, 2021

Study Completion (Actual)

November 9, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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