Heart Failure, SystolicHAPI-HFNCT04112576
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
An observational study of Heart Failure, Systolic and Heart Failure, Diastolic, run by Boston Scientific Corporation at 3 sites in 3 countries.
Trial summary
To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Systolic, Heart Failure, Diastolic
- What is being tested?
- Wearable cardiac monitor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 23 Jul 2020to 11 May 2022
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.
Who may be able to join
- Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
- Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
- HFrEF defined by documented evidence of EF ≤ 40% OR
- HFpEF defined by documented evidence of:
- EF ≥ 50% and no prior record of EF < 40%
- Evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 ESC guidelines
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- Able to understand and willing to provide written informed consent to participate in the trial
- Age 21 years old or greater
- Willing and able to participate in the required testing
Who cannot join
- Prior hospitalization, CV event or surgery within 6 weeks
- Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
- Patients with Active Implantable Medical Devices
- Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
- Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
- Subject is pregnant as indicated by patient record
- Patients with rash or open wound on torso locations where investigational devices will be placed
- Patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).
To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function
Read the detailed description
This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.
There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.
- Conditions
- Heart Failure, Systolic, Heart Failure, Diastolic
- Being tested
- Wearable cardiac monitor
- Keywords
- echocardiogram
- Medical subject headings
- Heart Failure, Systolic, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable cardiac monitorDevice
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | Participants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction. Receives: Device: Wearable cardiac monitor | |
| HFpEF | Participants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction. Receives: Device: Wearable cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Signal Detection
Characterize differences in cardiac physiology and dynamics between heart failure with preserved ejection fraction and heart failure with reduced ejection fraction patient populations using a wearable cardiac monitor prototype device.
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 posted2 Oct 2019
- Study start23 Jul 2020
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolyn Lam, MD, Principal investigator, National Heart Center Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112576
- Sponsor's protocol ID
- C2116
- Acronym
- HAPI-HF
- Status last verified
- Apr 2023
- First submitted
- 23 Sep 2019
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
- ClinicalTrials.gov ID
- NCT04112576
- Acronym / sponsor ID
- HAPI-HF / C2116
- Conditions
- Heart Failure, Systolic, Heart Failure, Diastolic
- Keywords
- echocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 2 Oct 2019 (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.
To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF).
To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function
Detailed description
This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF.
There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFrEF | – | Device: Wearable cardiac monitorParticipants that are diagnosed with NYHA class II or III heart failure with reduced ejection fraction. |
| HFpEF | – | Device: Wearable cardiac monitorParticipants that are diagnosed with NYHA class II or III heart failure with preserved ejection fraction. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are diagnosed with NYHA class II or III heart failure with preserved or reduced ejection fraction.
Key inclusion criteria (9 listed)
- Patients with NYHA class II or III heart failure defined by symptoms and signs of heart failure
- Documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
- HFrEF defined by documented evidence of EF ≤ 40% OR
- HFpEF defined by documented evidence of:
- EF ≥ 50% and no prior record of EF < 40%
Key exclusion criteria (8 listed)
- Prior hospitalization, CV event or surgery within 6 weeks
- Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs.
- Patients with Active Implantable Medical Devices
- Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
- Have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease
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 |
|---|---|---|
| Wearable cardiac monitorParticipants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals. | Device | HFpEF, HFrEF |
Primary outcome
Physiologic Signal Detection
Time frame: 12 months
Characterize differences in cardiac physiology and dynamics between heart failure with preserved ejection fraction and heart failure with reduced ejection fraction patient populations using a wearable cardiac monitor prototype device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- 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.
Carolyn Lam, MD principal investigator
National Heart Center Singapore
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic and Heart Failure, Diastolic, run by Boston Scientific Corporation at 3 sites in 3 countries.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Singapore, Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physiologic Signal Detection (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 7 Apr 2023.