Heart FailureNCT05972746
Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure
A study testing Telemonitoring with electronic alerts in people with Heart Failure and Acute Heart Failure, run by Instituto Cardiovascular de Buenos Aires at 1 site in Argentina.
Trial summary
This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- Telemonitoring with electronic alerts
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Oct 2022to 7 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization.
- Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.
- Residence in the metropolitan area of Buenos Aires
Who cannot join
- Pregnancy
- Alcohol or drug abuse
- Kidney failure in hemodialysis,
- Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate)
- Active cancer
- Life expectancy less than 1 year
Show all 10Show fewer
- Candidates for care home or institutional end of life
- Severe psychiatric illness
- Planned cardiac surgery
- Patient unable or unwilling to give informed consent to participate.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Instituto Cardiovascular de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1428
Lucrecia Maria Burgos, 541141057500, lburgos@icba.com.ar
Lucrecia M Burgos, MD
About this study
Official title: Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF
This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.
- Conditions
- Heart Failure, Acute Heart Failure
- Being tested
- Telemonitoring with electronic alerts, Standard of care
- Keywords
- telemonitoring, Heart Failure, Vulnerable phase
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring with electronic alertsDevice
Patients assigned to this group will receive standard care plus a telemonitoring program.
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring program with electronic alerts + Standard of care | Experimental | Not described Receives: Device: Telemonitoring with electronic alerts; Other: Standard of care |
| Standard of care | Placebo comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care behavior
The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)
Measured: 90 days
Secondary outcomes (7)
NT pro BNP
Measured: 90 days
Medication adherence
Measured: 90 days
Quality of life
The specific Quality of Life (QoL) related to heart failure will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), which consists of 21 items. Participants rate their perceptions of how heart failure and its treatment affect their daily life on a 6-point Likert scale ranging from 0 (no impairment) to 5 (very impaired). Therefore, lower scores indicate better specific QoL related to heart failure, and a change of 5 points is considered the minimum clinically significant change [30]. The MLHFQ yields a total QoL score and separate scores for the physical and emotional well-being sub-scales.
Measured: 90 days
First readmission for heart failure
Measured: 90 days
Total number of readmissions for heart failure
Measured: 90 days
Time to achieve the use of Guideline-Directed Medical Therapy
Measured: 90 days
Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start7 Oct 2022
- Primary completion7 Oct 2023 (estimated)
- Study completion7 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Cardiovascular de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972746
- Sponsor's protocol ID
- 0
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF
- ClinicalTrials.gov ID
- NCT05972746
- Acronym / sponsor ID
- 0
- Conditions
- Heart Failure, Acute Heart Failure
- Keywords
- telemonitoring, Heart Failure, Vulnerable phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Instituto Cardiovascular de Buenos AiresUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 7 Oct 2023 (estimated)
- Study completion
- 7 Nov 2023 (estimated)
- First posted
- 2 Aug 2023 (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.
This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring program with electronic alerts + Standard of care | Experimental | Device: Telemonitoring with electronic alerts, Other: Standard of care |
| Standard of care | Placebo comparator | Other: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization.
- Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.
- Residence in the metropolitan area of Buenos Aires
Key exclusion criteria (10 listed)
- Pregnancy
- Alcohol or drug abuse
- Kidney failure in hemodialysis,
- Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate)
- Active cancer
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 |
|---|---|---|
| Telemonitoring with electronic alertsPatients assigned to this group will receive standard care plus a telemonitoring program. | Device | Telemonitoring program with electronic alerts + Standard of care |
| Standard of careStandard of care | Other | Standard of care, Telemonitoring program with electronic alerts + Standard of care |
Primary outcome
Self-care behavior
Time frame: 90 days
The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)
7 secondary outcomes
NT pro BNP
Time frame: 90 days
Medication adherence
Time frame: 90 days
Quality of life
Time frame: 90 days
First readmission for heart failure
Time frame: 90 days
Total number of readmissions for heart failure
Time frame: 90 days
Time to achieve the use of Guideline-Directed Medical Therapy
Time frame: 90 days
Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring with electronic alerts in people with Heart Failure and Acute Heart Failure, run by Instituto Cardiovascular 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 10 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care behavior (time frame: 90 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 2 Aug 2023.