Abbott Initiates New Clinical Trial to Improve Outcomes in Patients with Advanced Heart Failure
Abbott (NYSE: ABT) announced the launch of TEAM-HF, a groundbreaking clinical trial aimed at improving outcomes for advanced heart failure patients. The study will enroll up to 850 patients across 75 sites worldwide, using Abbott's CardioMEMS™ HF System to monitor pulmonary artery pressures and identify patients who could benefit from early HeartMate 3™ left ventricular assist device intervention. The trial addresses a critical gap in heart failure treatment, as approximately 6.7 million Americans have heart failure, with numbers expected to reach 8.5 million by 2030. The study's primary and secondary endpoints will be evaluated at two years, with follow-up through five years.
Abbott (NYSE: ABT) ha annunciato il lancio di TEAM-HF, uno studio clinico innovativo volto a migliorare i risultati per i pazienti con insufficienza cardiaca avanzata. Lo studio iscriverà fino a 850 pazienti in 75 siti in tutto il mondo, utilizzando il sistema CardioMEMS™ HF di Abbott per monitorare le pressioni delle arterie polmonari e identificare i pazienti che potrebbero beneficiare di un intervento precoce con il dispositivo di assistenza ventricolare sinistra HeartMate 3™. La sperimentazione affronta una lacuna critica nel trattamento dell'insufficienza cardiaca, poiché circa 6,7 milioni di americani soffrono di insufficienza cardiaca, con previsioni che indicano un aumento a 8,5 milioni entro il 2030. Gli endpoint primari e secondari dello studio saranno valutati a due anni, con follow-up fino a cinque anni.
Abbott (NYSE: ABT) anunció el lanzamiento de TEAM-HF, un ensayo clínico innovador con el objetivo de mejorar los resultados para pacientes con insuficiencia cardíaca avanzada. El estudio inscribirá hasta 850 pacientes en 75 sitios en todo el mundo, utilizando el sistema CardioMEMS™ HF de Abbott para monitorear las presiones de la arteria pulmonar e identificar a los pacientes que podrían beneficiarse de una intervención temprana con el dispositivo de asistencia ventricular izquierda HeartMate 3™. El ensayo aborda una brecha crítica en el tratamiento de la insuficiencia cardíaca, ya que aproximadamente 6,7 millones de estadounidenses padecen insuficiencia cardíaca, y se espera que esa cifra alcance los 8,5 millones para 2030. Los objetivos primarios y secundarios del estudio se evaluarán a dos años, con un seguimiento de hasta cinco años.
Abbott (NYSE: ABT)는 진행성 심부전 환자의 결과를 개선하기 위한 혁신적인 임상 시험인 TEAM-HF의 출시를 발표했습니다. 이 연구는 전 세계 75개 사이트에서 최대 850명 환자를 모집하며, Abbott의 CardioMEMS™ HF 시스템을 사용하여 폐동맥 압력을 모니터링하고 조기 HeartMate 3™ 좌심실 보조 장치 개입으로 혜택을 볼 수 있는 환자를 식별합니다. 이 시험은 심부전 치료에서 중요한 격차를 다루고 있으며, 약 670만 명의 미국인이 심부전으로 고통받고 있고, 이 숫자는 2030년까지 850만 명에 이를 것으로 예상됩니다. 연구의 주요 및 2차 목표는 2년 후 평가되며, 5년까지 추적 관찰이 이루어집니다.
Abbott (NYSE: ABT) a annoncé le lancement de TEAM-HF, un essai clinique révolutionnaire visant à améliorer les résultats pour les patients souffrant d'insuffisance cardiaque avancée. L'étude prévoit d'inscrire jusqu'à 850 patients dans 75 sites à travers le monde, en utilisant le système CardioMEMS™ HF d'Abbott pour surveiller les pressions artérielles pulmonaires et identifier les patients qui pourraient bénéficier d'une intervention précoce avec le dispositif d'assistance ventriculaire gauche HeartMate 3™. L'essai répond à une carence critique dans le traitement de l'insuffisance cardiaque, car environ 6,7 millions d'Américains souffrent d'insuffisance cardiaque, et ce nombre devrait atteindre 8,5 millions d'ici 2030. Les objectifs primaires et secondaires de l'étude seront évalués après deux ans, avec un suivi de cinq ans.
Abbott (NYSE: ABT) hat die Einführung von TEAM-HF angekündigt, einer bahnbrechenden klinischen Studie, die darauf abzielt, die Ergebnisse für Patienten mit fortgeschrittener Herzinsuffizienz zu verbessern. Die Studie wird bis zu 850 Patienten an 75 Standorten weltweit rekrutieren und das CardioMEMS™ HF-System von Abbott verwenden, um die pulmonalen Arterien drücke zu überwachen und Patienten zu identifizieren, die von einem frühen Eingriff mit dem HeartMate 3™ Linksventrikulären Hilfssystem profitieren könnten. Die Studie hilft, eine kritische Lücke in der Behandlung von Herzinsuffizienz zu schließen, da etwa 6,7 Millionen Amerikaner an Herzinsuffizienz leiden, und die Zahl bis 2030 voraussichtlich 8,5 Millionen erreichen wird. Die primären und sekundären Endpunkte der Studie werden nach zwei Jahren bewertet, mit Follow-ups über fünf Jahre.
- First-of-its-kind clinical trial combining two Abbott technologies for heart failure treatment
- Large-scale study with 850 patients across 75 global sites
- Addresses an unmet medical need in heart failure treatment progression
- Potential to improve patient survival rates through earlier intervention
- Trial results won't be available for at least two years
- Long-term study commitment required (5-year follow-up)
- Current poor survival rates for end-stage heart failure patients (9-month median)
Insights
This clinical trial marks a significant advancement in heart failure treatment strategy. The TEAM-HF study's innovative approach of using CardioMEMS data to guide LVAD implementation timing could revolutionize treatment protocols. With
The trial's scope of 850 patients across 75 sites is substantial enough to generate statistically significant data. If successful, this could establish new standard-of-care protocols, potentially expanding the addressable market for both CardioMEMS and HeartMate 3. The focus on earlier intervention could significantly improve survival rates, currently at just 9 months for end-stage patients on IV medications.
The 5-year follow-up period demonstrates commitment to gathering comprehensive long-term data, which could strengthen reimbursement arguments and drive broader adoption. This could lead to increased device utilization and market share growth in the expanding heart failure market, projected to reach 8.5 million patients by 2030.
- The first-of-its-kind TEAM-HF study seeks to improve clinical outcomes in patients with worsening heart failure
- Trial establishes new, objective criteria to identify patients most at risk for developing end-stage heart failure and potentially offer life-saving therapeutic options sooner in their disease progression
ABBOTT PARK, Ill., Oct. 24, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced a new, first-of-its-kind clinical trial designed to improve outcomes in patients with worsening heart failure who could benefit from advanced therapy options. The TEAM-HF trial, which is planned to enroll up to 850 patients across 75 sites worldwide, will measure pulmonary artery pressures (PAP) using Abbott's CardioMEMS™ HF System to objectively identify advanced heart failure patients at high risk of mortality who could benefit from a life-saving HeartMate 3™ left ventricular assist device (LVAD, or heart pump) earlier in their disease progression.
Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness, and swollen ankles. Approximately 6.7 million people in
"The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients. We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure, but also enable rapid access to life saving heart pumps. This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation," said Jennifer Cowger, M.D., medical director of mechanical circulatory support and section head of the advanced heart failure program at
TEAM-HF: Deploying a New Approach to Therapy Decisions
Patients with end-stage heart failure who rely on IV-administered heart failure medications designed to strengthen the heart's blood pumping ability have poor outcomes with a median survival of nine months.2 Guideline recommendations for treating patients who depend on these medications include advanced therapies such as LVADs. However, patients who are not yet dependent on medication also have a poor clinical prognosis but are often not referred for these advanced options until their symptoms worsen. This delay is partly due to the lack of objective measures to identify patients who would most benefit from an LVAD.
The TEAM-HF trial will deploy a novel approach to assess the impact of earlier interventions in patients with worsening heart failure. Investigators will first examine PAP data securely collected from participants using Abbott's CardioMEMS™ HF System. The CardioMEMS sensor, placed in the pulmonary artery during a minimally invasive outpatient procedure, monitors pulmonary artery pressure changes over time. If pressures do not go down with guideline directed medical therapy, the TEAM-HF trial will seek to prove that such patients will benefit from advanced therapies. These patients will be randomized to receive either the HeartMate 3 LVAD implant or continued treatment with their existing heart failure medications. Patients whose existing medications reduce their PAP levels will enter a single arm registry where they will continue to be managed based on data from their CardioMEMS sensor.
"As the only healthcare company in the world that has developed medical devices designed to treat people at each stage of heart failure, our hope is that the TEAM-HF study will revolutionize care management for these patients and their families. Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones," said Keith Boettiger, vice president, Abbott's heart failure business. "By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study."
Enrollment in TEAM-HF will commence shortly at sites across the
Decisions regarding the medical management of HeartMate 3 patients should be done by clinicians after fully considering potential risks and benefits for each individual.
Indications and Important Safety Information
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1. | Bozkurt, et. al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023; 29(10): 1412–1451. |
2. | Hashim, et al. Clinical Characteristics and Outcomes of Intravenous Inotropic Therapy in Advanced Heart Failure. Circ Heart Fail. 2015 Sep;8(5):880-6. |
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