An interventional study of Wearable Monitoring Device for Heart Failure in Heart Failure, sponsored by Zoll Medical Corporation. Not yet recruiting at 9 sites in 9 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Zoll Medical Corporation · Not applicable, Interventional, and Treatment
Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission.
This study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure.
Participants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure.
Participants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life.
The goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.
The REMODEL-HF study is a prospective, multi-center, randomized, open-label clinical investigation designed to evaluate whether the use of HFMS in addition to usual care improves clinical outcomes in patients recently hospitalized for acute heart failure.
Approximately 800 participants will be enrolled and randomized in a 1:1 ratio to either: standard of care alone (control group), or standard of care plus HFMS-guided management (intervention group).
The primary objective is to determine whether HFMS-guided management results in improved overall clinical outcomes compared to usual care. Outcomes of interest include major clinical events such as cardiovascular death and heart failure hospitalization, as well as earlier indicators of clinical deterioration and changes in relevant biomarkers.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 800 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Biomarker criteria for persistent congestion:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device.
Participants receive standard medical care in addition to remote monitoring using the Heart Failure Management System (HFMS). Clinical teams review device data and may adjust treatment based on observed trends and alerts.
Device: Wearable Monitoring Device for Heart Failure
Participants assigned to the intervention group will use a noninvasive wearable physiological monitoring device (Heart Failure Management System, HFMS) designed to continuously collect data related to cardiopulmonary status, including heart rate, respiratory parameters, activity levels, and indicators of fluid status (Thoraic Fluid Index = TFI). Clinical care teams perform regular reviews of device-derived data and may respond to alerts or trends suggestive of worsening heart failure. Based on these data, the care team may adjust patient management, including modification of guideline-directed medical therapy or scheduling of follow-up assessments. The device does not deliver therapy and is used to support clinical decision-making in the outpatient management of heart failure.
Hierarchical Composite Outcome (Win Ratio)
A hierarchical composite outcome comparing the intervention and control groups using a win ratio approach. The components are prioritized as follows: (1) cardiovascular death, (2) heart failure hospitalization, (3) Unplanned visit (emergency room or other emergency facilities) requiring intravenous diuretic treatment, and (4) change in NT-proBNP concentration. Participants are compared pairwise, with outcomes evaluated sequentially according to this hierarchy.
Time frame: 90 days
Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)
Percentage of participants reaching target doses of guideline-directed medical therapy for heart failure during the first 90 days after randomization.
Time frame: 90 days
Quality of Life Assessed by KCCQ-12
Change in health-related quality of life measured using validated questionnaire : the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: Baseline, 90 days,180 days and 365 days
Time to First Clinical Event Composite
Time to First Occurrence of Cardiovascular Death, Heart Failure Hospitalization, or Unplanned Visit Requiring Intravenous Diuretic Treatment
Time frame: Up to 365 days
Quality of Life Assessed by EQ-5D-5L
Change in health-related quality of life measured using validated questionnaire : the EQ-5D-5L
Time frame: Baseline, 90 days,180 days and 365 days
Hierarchical Composite Outcome (Win Ratio at 1 Year)
Hierarchical composite outcome using the same win ratio methodology as the primary endpoint, evaluated at 1 year.
Time frame: 365 days
Cardiovascular Death
Occurrence of death due to cardiovascular causes.
Time frame: 90 days and 365 days
Heart Failure Hospitalization
Occurrence of hospitalization due to heart failure.
Time frame: 90 days and 365 days
Unplanned Visit Requiring Intravenous Diuretic Treatment
Occurrence of an unplanned visit requiring intravenous diuretic treatment. Scheduled or planned intravenous diuretic treatments are not considered events.
Time frame: 90 days and 365 days
NT-proBNP Response
Change in NT-proBNP concentration from baseline. Response defined as ≥30% decrease from baseline.
Time frame: Baseline to 90 days
Plan to share: No
Start is estimated for Oct 2026; primary completion for Aug 2028, 22 months later.
Of 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's planned 22 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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