Remote Monitoring and Optimization of Heart Failure Therapy

NCT07622472 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 90d0278101253160
• Study Type: interventional
• Target: 800
• Locations: 9 countries
• Sites: 9

Brief 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. 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.

Conditions

Heart Failure

Keywords

Heart Failure, Remote Monitoring, Wearable Device

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (9)

• Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)

  90 days

• Quality of Life Assessed by KCCQ-12

  Baseline, 90 days,180 days and 365 days

• Time to First Clinical Event Composite

  Up to 365 days

• Quality of Life Assessed by EQ-5D-5L

  Baseline, 90 days,180 days and 365 days

• Hierarchical Composite Outcome (Win Ratio at 1 Year)

  365 days

Study Arms (2)

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.

Device: Wearable Monitoring Device for Heart Failure

Interventions

Wearable Monitoring Device for Heart Failure DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (9)

CHU Nancy

Nancy, Grand Est, 54000, France

Location

Justus-Liebig University Giessen

Giessen, 35390, Germany

Location

Policlinico Casilino

Roma, Italy

Location

UMC Utrecht

Utrecht, Netherlands

Location

PIM MSWiA Hospital

Warsaw, Poland

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Uppsala University Hospital

Uppsala, Sweden

Location

University Zurich

Zurich, Switzerland

Location

Southampton University Hospital NHS Foundation Trust

Southampton, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 37216272 BACKGROUND

• Mebazaa 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.

  PMID: 36356631 BACKGROUND

• Boehmer 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.

  PMID: 39387771 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Manon Lemaire, Master

CONTACT

+33 (0)6 33 57 18 52; mlemaire@zoll.com

Lars Weber, PhD

CONTACT

+49 (0) 151 611 404 98; lweber@zoll.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); PL (1); FR (1); ES (1); NL (1); SE (1); CH (1); GB (1); DE (1)