Heart FailurePhase 2/3NCT04738279

The CASCADE HF Soft Launch and Calibration Phase I and II

A Phase 2/3 study testing Non-Invasive Continuous Remote Patient Monitoring and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring in people with Heart Failure, run by Endeavor Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Non-Invasive Continuous Remote Patient Monitoring and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2020to 30 Oct 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient is an inpatient at NorthShore University HealthSystem
Patient is on the heart failure consult list
Patient has a history of heart failure
Patient received at least one dose of IV diuretics at index hospitalization
Patient is discharging with NorthShore Home Health services
Symptoms corresponding to New York Heart Association function class II-IV

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Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%)
Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
Patient is at least 18 years of age
Patient is fluent in English
Patient agrees to protocol-required procedures

Who cannot join

Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone
Patient has allergy to hydrocolloid adhesives
Patient has present skin damage preventing them from wearing a study device
Patient has renal dysfunction requiring dialysis
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients

Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.

Conditions: Heart Failure
Being tested: Non-Invasive Continuous Remote Patient Monitoring, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-Invasive Continuous Remote Patient MonitoringDevice
Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient MonitoringOther
Survey and qualitative interviewing of participants

Study groups in NCT04738279
Study group	Role	What they receive
Phase I: Soft Launch (120 days)	Experimental	The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol. Receives: Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Phase II: Calibration (210 days)	Experimental	After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes Receives: Device: Non-Invasive Continuous Remote Patient Monitoring; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Attrition Rate
Drop out from study
Measured: 30 days from patient discharge date
Enrollment Rate
Enrollment rate for entire patient cohort
Measured: Through study completion, an average of 30 days for each patient

Secondary outcomes (2)

Number of Participants With Diuretic Escalation
Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.
Measured: 30 days from patient discharge date
30-day Readmission
30-day readmission to hospital
Measured: 30 days from patient discharge date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202030 Oct 2021

First posted4 Feb 2021
Study start14 Dec 2020
Primary completion30 Oct 2021
Study completion30 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2/3
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04738279
Sponsor's protocol ID: EH20-288 Cascade Soft Launch
Status last verified: Oct 2023
First submitted: 27 Jan 2021
Last updated: 3 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients
ClinicalTrials.gov ID: NCT04738279
Acronym / sponsor ID: EH20-288 Cascade Soft Launch
Conditions: Heart Failure
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Endeavor HealthUniversity, hospital or other
Collaborators: physIQ, Inc., Carnegie Mellon University, Northwestern University
Study start: 14 Dec 2020 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 30 Oct 2021 (actual)
First posted: 4 Feb 2021 (actual)
Results: Posted 16 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase I: Soft Launch (120 days)	Experimental	Device: Non-Invasive Continuous Remote Patient Monitoring, Other: Affective Analysis of Participant Response to Continuous Remote Patient MonitoringThe study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Phase II: Calibration (210 days)	Experimental	Device: Non-Invasive Continuous Remote Patient Monitoring, Other: Affective Analysis of Participant Response to Continuous Remote Patient MonitoringAfter learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patient is an inpatient at NorthShore University HealthSystem
Patient is on the heart failure consult list
Patient has a history of heart failure
Patient received at least one dose of IV diuretics at index hospitalization
Patient is discharging with NorthShore Home Health services

Key exclusion criteria (5 listed)

Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone
Patient has allergy to hydrocolloid adhesives
Patient has present skin damage preventing them from wearing a study device
Patient has renal dysfunction requiring dialysis
Pregnancy

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
Non-Invasive Continuous Remote Patient MonitoringContinuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway	Device	Phase I: Soft Launch (120 days), Phase II: Calibration (210 days)
Affective Analysis of Participant Response to Continuous Remote Patient MonitoringSurvey and qualitative interviewing of participants	Other	Phase I: Soft Launch (120 days), Phase II: Calibration (210 days)

Primary outcome

Attrition Rate
Time frame: 30 days from patient discharge date
Drop out from study
Enrollment Rate
Time frame: Through study completion, an average of 30 days for each patient
Enrollment rate for entire patient cohort

2 secondary outcomes

Number of Participants With Diuretic Escalation
Time frame: 30 days from patient discharge date
30-day Readmission
Time frame: 30 days from patient discharge date

Results and safety

Results posted to the registry on 16 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I: Soft Launch (120 Days)	5	4
Phase II: Calibration (210 Days)	15	13

Primary outcome: Attrition Rate

Time frame: 30 days from patient discharge date. Count of participants. Unit: Participants

Measure	Phase I: Soft Launch (120 Days) n = 5	Phase II: Calibration (210 Days) n = 15
Value	1	2

Primary outcome: Enrollment Rate

Time frame: Through study completion, an average of 30 days for each patient. Count of participants. Unit: Participants

Measure	Phase I: Soft Launch (120 Days) n = 43	Phase II: Calibration (210 Days) n = 431
Value	5	15

Population analysed: Overall number of participants analyzed reflects the number of participants who were screened for phase I and phase II, respectively.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: We collected adverse event data over the 30-day participation period for each participant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I: Soft Launch (120 Days)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Phase II: Calibration (210 Days)	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

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.

Nirav S Shah, MD, MPH principal investigator

Endeavor Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: finished, as of the sponsor's last update on 3 Oct 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 United States. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Attrition Rate (time frame: 30 days from patient discharge date). The study lists 2 primary outcomes in all. 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 NCT04738279.

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 3 Oct 2023.