Heart FailureNCT06126848
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation
A study testing Ambient sensor system in people with Heart Failure, run by Nisha Arenja.
Trial summary
Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ambient sensor system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Mar 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- admitted to hospital for worsening HF
- age ≥ 70 years
- LVEF < 50% and need of diuretics
- NYHA II or III
- living alone
- willing to participate with informed consent.
Who cannot join
- Major depression (PHQ 9-score >9)
- being on hemodialysis
- had been admitted to hospital for any reason within 7 days before HF decompensation.
- patients with a left ventricular assist device
- coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.
About this study
Official title: Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home
Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.
Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)
- Conditions
- Heart Failure
- Being tested
- Ambient sensor system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient sensor systemDevice
Main study: A contactless non-intrusive ambient sensor system including infrared motion sensors combined with a contactless Emfit bed sensor will be installed in the home of single living study patients by using a commercially available System (Domo Health®, Lausanne) after informed consent has been obtained. Sensor data are prospectively followed over 3-6 months for predefined indicators of health deterioration. If indicators for health deterioration are present, patients will be called in to the hospital for cardiology consult by the study team including blood analysis for follow-up of BNP values and if necessary, therapy adaption.
| Study group | Role | What they receive |
|---|---|---|
| Observation Cohort | Other | Not described Receives: Device: Ambient sensor system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of ambient sensor derived digital biomarkers
Sensitivity and specificity of a combination of ambient sensor derived digital biomarker for the prediction of brain natriuretic peptide (BNP) increase of ≥ 20% compared to baseline value.
Measured: 6 months
Secondary outcomes (3)
Outcome assessment
re-hospitalizations, cardiovascular death, all-cause death
Measured: 6 months
Quality of life (heart failure symptoms) - KCCQ
KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 6 months
System Usability Scale (SUS)
SUS score 0-100; 80.3 or higher is an A. People will recommend it to their friends 68 or there abouts gets you a C. You are doing OK but could improve 51 or under gets you a big fat F. Make usability your priority now and fix this fast.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nisha Arenja
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nisha Arenja, Kantonsspital Olten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126848
- Sponsor's protocol ID
- eHealth-HF
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haas K, Scheidegger-Balmer F, Meichtry A, Vogeli B, Arenja N, Buluschek P, Saner H. Association Between Refrigerator Openings and Protein Intake After Hospitalization for Heart Failure Decompensation: Protocol for a Prospective Cohort Pilot Study. JMIR Res Protoc. 2025 Aug 18;14:e66299. doi: 10.2196/66299.
PubMed 40824685Vogeli B, Arenja N, Schutz N, Nef T, Buluschek P, Saner H. Evaluation of Ambient Sensor Systems for the Early Detection of Heart Failure Decompensation in Older Patients Living at Home Alone: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2024 May 31;13:e55953. doi: 10.2196/55953.
PubMed 38820577
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home
- ClinicalTrials.gov ID
- NCT06126848
- Acronym / sponsor ID
- eHealth-HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nisha ArenjaUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Nov 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.
Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.
Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Cohort | Other | Device: Ambient sensor system |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- admitted to hospital for worsening HF
- age ≥ 70 years
- LVEF < 50% and need of diuretics
- NYHA II or III
- living alone
Key exclusion criteria (5 listed)
- Major depression (PHQ 9-score >9)
- being on hemodialysis
- had been admitted to hospital for any reason within 7 days before HF decompensation.
- patients with a left ventricular assist device
- coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.
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 |
|---|---|---|
| Ambient sensor systemMain study: A contactless non-intrusive ambient sensor system including infrared motion sensors combined with a contactless Emfit bed sensor will be installed in the home of single living study patients by using a commercially available System (Domo Health®, Lausanne) after informed consent has been obtained. Sensor data are prospectively followed over 3-6 months for predefined indicators of health deterioration. If indicators for health deterioration are present, patients will be called in to the hospital for cardiology consult by the study team including blood analysis for follow-up of BNP values and if necessary, therapy adaption. | Device | Observation Cohort |
Primary outcome
Sensitivity and specificity of ambient sensor derived digital biomarkers
Time frame: 6 months
Sensitivity and specificity of a combination of ambient sensor derived digital biomarker for the prediction of brain natriuretic peptide (BNP) increase of ≥ 20% compared to baseline value.
3 secondary outcomes
Outcome assessment
Time frame: 6 months
Quality of life (heart failure symptoms) - KCCQ
Time frame: 6 months
System Usability Scale (SUS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 40824685Haas K, Scheidegger-Balmer F, Meichtry A, Vogeli B, Arenja N, Buluschek P, Saner H. Association Between Refrigerator Openings and Protein Intake After Hospitalization for Heart Failure Decompensation: Protocol for a Prospective Cohort Pilot Study. JMIR Res Protoc. 2025 Aug 18;14:e66299. doi: 10.2196/66299.
- Derived from this study: PubMed 38820577Vogeli B, Arenja N, Schutz N, Nef T, Buluschek P, Saner H. Evaluation of Ambient Sensor Systems for the Early Detection of Heart Failure Decompensation in Older Patients Living at Home Alone: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2024 May 31;13:e55953. doi: 10.2196/55953.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ambient sensor system in people with Heart Failure, run by Nisha Arenja.
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 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sensitivity and specificity of ambient sensor derived digital biomarkers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06126848, which also lists 2 linked publications.
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 14 Nov 2023.