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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04643184
Other study ID # 5452
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2, 2020
Est. completion date November 9, 2021

Study information

Verified date December 2022
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 37
Est. completion date November 9, 2021
Est. primary completion date November 9, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Argentina Rodrigo Aguirre Buenos Aires C.a.b.a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 Admission
Primary Hospital admission Number of hospital admission for any cause within 30 days 30 days
Secondary Mortality Number of deaths from any cause within 30 days 30 days
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