Heart Failure; With DecompensationNCT04643184
Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
A study testing Management Program in people with Heart Failure; With Decompensation and Fragility, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure; With Decompensation, Fragility
- What is being tested?
- Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Dec 2020to 9 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Decompensated heart failure
- FRAIL scale equal to 3 or more points
- Permanent residence in the Metropolitan Area of Buenos Aires
Who cannot join
- Refusal to participate in the study
- Terminal oncology or cardiological disease
- Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis)
- Patients followed by geriatrics prior to admission
- Simultaneous participation in another research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Heart Failure; With Decompensation, Fragility
- Being tested
- Management Program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Management Program | Experimental | 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. Receives: Other: Management Program |
| Usual Care | No intervention | Usual care during hospitalizacion and discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission
Number of hospital admission for any cause within 30 days
Measured: 30 days
Secondary outcomes (1)
Mortality
Number of deaths from any cause within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start2 Dec 2020
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Why it stopped: Poor enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Co-management 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- César Belziti, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643184
- Sponsor's protocol ID
- 5452
- Status last verified
- Dec 2022
- First submitted
- 19 Nov 2020
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04643184
- Acronym / sponsor ID
- 5452
- Conditions
- Heart Failure; With Decompensation, Fragility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment rate
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Co-management 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.
| Arm | Type | Receives |
|---|---|---|
| Management Program | Experimental | Other: Management ProgramComanagement 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. |
| Usual Care | No intervention | –Usual care during hospitalizacion and discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older
- Decompensated heart failure
- FRAIL scale equal to 3 or more points
- Permanent residence in the Metropolitan Area of Buenos Aires
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Terminal oncology or cardiological disease
- Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis)
- Patients followed by geriatrics prior to admission
- Simultaneous participation in another research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management ProgramJoint 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. | Other | Management Program |
Primary outcome
Hospital admission
Time frame: 30 days
Number of hospital admission for any cause within 30 days
1 secondary outcome
Mortality
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Poor enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Heart Failure; With Decompensation
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Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Heart Failure; With Decompensation
Recruiting
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Heart Failure, Cardiorenal Syndrome
Recruiting
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
MASLD, Liver Cirrhosis, Alcoholic
Active, not recruitingObservational study
Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
Heart Failure, Heart Failure NYHA Class IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
César Belziti, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management Program in people with Heart Failure; With Decompensation and Fragility, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.