Heart FailureREMODEL-HFNCT07622472
Remote Monitoring and Optimization of Heart Failure Therapy
A study testing Wearable Monitoring Device for Heart Failure in people with Heart Failure, run by Zoll Medical Corporation at 9 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Wearable Monitoring Device for Heart Failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 9 sitesin 9 countries
- Study dates
- 1 Oct 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Ability and willingness to provide written informed consent and comply with study procedures
- Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq/L (mmol/L).
- Biomarker criteria for persistent congestion:
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- NT-proBNP >1500 pg/mL at the time of admission, and;
- NT-proBNP >1000 pg/mL >=3 days after initial admission measure
- At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment.
Who cannot join
- Age < 18 years
- Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.
- Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).
- Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.
- Cardiac surgery within 3 months prior to Screening
Show all 14Show fewer
- Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded.
- Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Adhesive allergy/sensitivity (e.g., acrylic adhesives).
- Compromised skin at the device application site (wound, severe dermatitis, etc.) .
- Having a prescribed wearable cardioverter defibrillator
- Pulmonary artery pressure implant (e.g. CardioMems)
- Expected survival <1 year
Trial locations and contacts
9 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 9 countries
France1 site
CHU Nancy
Nancy, Grand Est, 54000
Sarah Klepp, PhD, +49 (0) 151 40373 869, sarah.klepp@zoll.com
Nicolas Girerd, Professor
Germany1 site
Justus-Liebig University Giessen
Giessen, 35390
Nour Katnahji, PhD, +49 (0) 170 8862 141, nour.katnahji@zoll.com
Brigit Assmus, MD
Italy1 site
Policlinico Casilino
Roma
Manon Lemaire, Master, +33 (0)6 33 57 18 52, mlemaire@zoll.com
Netherlands1 site
University Medical Centre Groningen
Groningen
Lena Gagesch, +49 (0) 151 14438040, Lena.Gagesch@zoll.com
Jozine Ter Maaten, Prof, Dr
Poland1 site
PIM MSWiA Hospital
Warsaw
Manon Lemaire, Master, +33 (0)6 33 57 18 52, mlemaire@zoll.com
Agnieszka Pawlak, Professor
Spain1 site
Hospital Universitario 12 de Octubre
Madrid
Manon Lemaire, Master, +33 (0)6 33 57 18 52, mlemaire@zoll.com
Javier De Juan Bagudá, Dr
Sweden1 site
Uppsala University Hospital
Uppsala
Manon Lemaire, Master, +33 (0)6 33 57 18 52, mlemaire@zoll.com
Switzerland1 site
USB Basel
Basel, 4031
Manon Lemaire, Master, +33 (0)6 33 57 18 52, mlemaire@zoll.com
Lucas Lauder, Dr
United Kingdom1 site
Southampton University Hospital NHS Foundation Trust
Southampton
Olta Ibruli, PhD, +49 (0) 171 152 32 94, olta.ibruli@zoll.com
Peter COWBURN, MD
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Wearable Monitoring Device for Heart Failure
- Keywords
- Heart Failure, Remote Monitoring, Wearable Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Monitoring Device for Heart FailureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device. |
| Intervention Group | Active comparator | 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. Receives: Device: Wearable Monitoring Device for Heart Failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (9)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 365 days
Cardiovascular Death
Occurrence of death due to cardiovascular causes.
Measured: 90 days and 365 days
Heart Failure Hospitalization
Occurrence of hospitalization due to heart failure.
Measured: 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.
Measured: 90 days and 365 days
NT-proBNP Response
Change in NT-proBNP concentration from baseline. Response defined as ≥30% decrease from baseline.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622472
- Sponsor's protocol ID
- 90d0278
- Other IDs
- 101253160
- Acronym
- REMODEL-HF
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Scholte NTB, Gurgoze MT, Aydin D, Theuns DAMJ, Manintveld OC, Ronner E, Boersma E, de Boer RA, van der Boon RMA, Brugts JJ. Telemonitoring for heart failure: a meta-analysis. Eur Heart J. 2023 Aug 14;44(31):2911-2926. doi: 10.1093/eurheartj/ehad280.
PubMed 37216272Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
PubMed 36356631Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.
PubMed 39387771
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring and Optimization of Heart Failure Therapy
- ClinicalTrials.gov ID
- NCT07622472
- Acronym / sponsor ID
- REMODEL-HF / 90d0278
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Remote Monitoring, Wearable Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Jun 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device. |
| Intervention Group | Active comparator | Device: Wearable Monitoring Device for Heart FailureParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Ability and willingness to provide written informed consent and comply with study procedures
- Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq/L (mmol/L).
Key exclusion criteria (14 listed)
- Age < 18 years
- Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.
- Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).
- Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.
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 Monitoring Device for Heart FailureParticipants 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. | Device | Intervention Group |
Primary outcome
Hierarchical Composite Outcome (Win Ratio)
Time frame: 90 days
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.
9 secondary outcomes
Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)
Time frame: 90 days
Quality of Life Assessed by KCCQ-12
Time frame: Baseline, 90 days,180 days and 365 days
Time to First Clinical Event Composite
Time frame: Up to 365 days
Quality of Life Assessed by EQ-5D-5L
Time frame: Baseline, 90 days,180 days and 365 days
Hierarchical Composite Outcome (Win Ratio at 1 Year)
Time frame: 365 days
Cardiovascular Death
Time frame: 90 days and 365 days
Heart Failure Hospitalization
Time frame: 90 days and 365 days
Unplanned Visit Requiring Intravenous Diuretic Treatment
Time frame: 90 days and 365 days
NT-proBNP Response
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 37216272Scholte NTB, Gurgoze MT, Aydin D, Theuns DAMJ, Manintveld OC, Ronner E, Boersma E, de Boer RA, van der Boon RMA, Brugts JJ. Telemonitoring for heart failure: a meta-analysis. Eur Heart J. 2023 Aug 14;44(31):2911-2926. doi: 10.1093/eurheartj/ehad280.
- Background: PubMed 36356631Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
- Background: PubMed 39387771Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.
- 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.
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Monitoring Device for Heart Failure in people with Heart Failure, run by Zoll Medical Corporation at 9 sites in 9 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 14 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Italy, Netherlands, Poland and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Lemaire, Master (+33 (0)6 33 57 18 52, mlemaire@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Outcome (Win Ratio) (time frame: 90 days). 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 NCT07622472, which also lists 3 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 5 Oct 2026.