Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

Fragility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04643184
• Other study ID #: 5452
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fragility
• Heart Failure
• Heart Failure; With Decompensation

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