Remote Monitoring and Optimization of Heart Failure Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Hierarchical Composite Outcome (Win Ratio) [Срок оценки: 90 days]

Вторичные конечные точки (9)

• Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT) [Срок оценки: 90 days]
• Quality of Life Assessed by KCCQ-12 [Срок оценки: Baseline, 90 days,180 days and 365 days]
• Time to First Clinical Event Composite [Срок оценки: Up to 365 days]
• Quality of Life Assessed by EQ-5D-5L [Срок оценки: Baseline, 90 days,180 days and 365 days]
• Hierarchical Composite Outcome (Win Ratio at 1 Year) [Срок оценки: 365 days]
• Cardiovascular Death [Срок оценки: 90 days and 365 days]
• Heart Failure Hospitalization [Срок оценки: 90 days and 365 days]
• Unplanned Visit Requiring Intravenous Diuretic Treatment [Срок оценки: 90 days and 365 days]
• NT-proBNP Response [Срок оценки: Baseline to 90 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Nancy — Nancy

Германия · 1 центр

• Justus-Liebig University Giessen — Giessen

Италия · 1 центр

• Policlinico Casilino — Roma

Нидерланды · 1 центр

• UMC Utrecht — Utrecht

Польша · 1 центр

• PIM MSWiA Hospital — Warsaw

Испания · 1 центр

• Hospital Universitario 12 de Octubre — Madrid

Швеция · 1 центр

• Uppsala University Hospital — Uppsala

Швейцария · 1 центр

• University Zurich — Zurich

Великобритания · 1 центр

• Southampton University Hospital NHS Foundation Trust — Southampton

Публикации

• 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
• 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 PMID 36356631
• 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

Идентификаторы

NCT: NCT07622472 · 90d0278 · 101253160

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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