ClinicalTrials.gg
TerminatedNCT04643184Updated Dec 9, 2022

Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

An interventional study of Management Program in Heart Failure; With Decompensation and Fragility, sponsored by Hospital Italiano de Buenos Aires. Terminated at 1 site in Argentina. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Hospital Italiano de Buenos Aires · Not applicable, Interventional, and Health services research

Why this study was terminated
Poor enrollment rate
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Heart Failure; With Decompensation
  • Fragility

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03

In context

Heart Failure

5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 37 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.

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Lead sponsor

Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

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

Study arms

  • 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

  • No intervention
    Usual Care

    Usual care during hospitalizacion and discharge.

Interventions

  • OtherManagement 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.

06

What researchers measure

Primary outcomes

  1. Hospital admission

    Number of hospital admission for any cause within 30 days

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    Number of deaths from any cause within 30 days

    Time frame: 30 days

Other outcomes

  1. Prevalence of fragility

    The proportion of patients with a FRAIL scale equal to 3 or more points of the total number of patients hospitalized for heart failure

    Time frame: Admission

07

Study locations

1 site
  • Rodrigo Aguirre
    Buenos Aires, C.a.b.a C1199, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Nov 2021, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2020
First posted
Nov 25, 2020
StartActual
Dec 2, 2020
Primary completionActual
Nov 9, 2021
CompletionActual
Nov 9, 2021
Last update
Dec 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04643184
Responsible party
Sponsor
First posted
Nov 25, 2020
Start date
Dec 2, 2020
Primary completion
Nov 9, 2021
Completion
Nov 9, 2021
Last update
Dec 9, 2022

Study contacts

César Belziti, MD
principal investigator · Hospital Italiano de Buenos Aires

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 terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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