Heart FailureIMPACT-HFNCT05653726
Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
A study testing Telemonitoring follow-up using medical devices and telematic consultations in people with Heart Failure, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring follow-up using medical devices and telematic consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSpain
- Study dates
- 29 Nov 2023to 31 Dec 2025
- 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
- Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.
- Admitted for decompensation of chronic HF.
- Admitted for HF decompensation ≥30 days and ≤6 months.
- HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or >50% increase in loop diuretic dose.
- With previous optimized prognostic medical treatment.
- Under treatment with loop diuretic drugs.
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- New York Heart Association functional class II, III or IV.
- Hemodynamic instability.
- Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days.
- Uncontrolled arrhythmias
- On waiting list for transplantation (any organ) or other cardiac surgery.
- Advanced mechanical circulatory support.
- Chronic renal disease on hemodialysis.
- Life expectancy less than 1 year.
- Moderate-severe cognitive impairment.
- Manifest inability to use a technological system.
- Institutionalized.
- Limiting psychiatric pathology.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid
Juan Carlos López-Azor, PhD, +34628026462, lopez.gcia.juan.carlos@gmail.com
About this study
Official title: Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:
- Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure?
- Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients?
- Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team.
Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring follow-up using medical devices and telematic consultations
- 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 follow-up using medical devices and telematic consultationsOther
Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram. Receives: Other: Telemonitoring follow-up using medical devices and telematic consultations |
| Control gropu | No intervention | Usual care follow-up group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care costs
Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.
Measured: 12 months
Secondary outcomes (8)
Non-health care costs
Sum of informal costs (care provided by people who are not health or social care professionals) and professional costs (home help, tele-health, tele-assistance, ambulatory care centers and use of nursing homes)
Measured: 12 months
Symptoms
Measured using New York Heart Association dyspnea scale
Measured: 12 months
Care burden of caregivers
Measured using Zarit scale (values 0 to 88)
Measured: 12 months
Number of hospital admissions
For any cause, cardiovascular and for heart failure.
Measured: 12 months
Mortality
For any cause and for cardiovascular cause
Measured: 12 months
Patient satisfaction with service
Measured using a customer satistaction questionnaire (values 0 to 20), with higer scores meaning
Measured: 12 months
Adherence to the telemonitoring protocolo
Number of transmissions made versus planned at 12 months.
Measured: 12 months
Quality of life variation
Euroqol-5D-5L questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start29 Nov 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Puerta de Hierro University Hospital
- Responsible party
- Principal investigator, Juan Carlos López-Azor, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653726
- Sponsor's protocol ID
- HU12Octubre
- Acronym
- IMPACT-HF
- Status last verified
- Feb 2024
- First submitted
- 28 Nov 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
- ClinicalTrials.gov ID
- NCT05653726
- Acronym / sponsor ID
- IMPACT-HF / HU12Octubre
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Puerta de Hierro University Hospital
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2022 (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.
The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:
- Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure?
- Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients?
- Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team.
Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Other: Telemonitoring follow-up using medical devices and telematic consultationsFollow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram. |
| Control gropu | No intervention | –Usual care follow-up group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.
- Admitted for decompensation of chronic HF.
- Admitted for HF decompensation ≥30 days and ≤6 months.
- HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or >50% increase in loop diuretic dose.
- With previous optimized prognostic medical treatment.
Key exclusion criteria (0 listed)
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 follow-up using medical devices and telematic consultationsHome telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months | Other | Telemonitoring group |
Primary outcome
Health care costs
Time frame: 12 months
Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.
8 secondary outcomes
Non-health care costs
Time frame: 12 months
Symptoms
Time frame: 12 months
Care burden of caregivers
Time frame: 12 months
Number of hospital admissions
Time frame: 12 months
Mortality
Time frame: 12 months
Patient satisfaction with service
Time frame: 12 months
Adherence to the telemonitoring protocolo
Time frame: 12 months
Quality of life variation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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 follow-up using medical devices and telematic consultations in people with Heart Failure, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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 18 inclusion and 0 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 27 Nov 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos López-Azor García, MD, PhD (+34628026462, lopez.gcia.juan.carlos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care costs (time frame: 12 months). 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 27 Nov 2024.