Abbott Begins TEAM-HF Trial with Goal of Improving Heart Failure Outcomes

Abbott has begun a new, first-of-its kind clinical trial to improve outcomes in patients with worsening heart failure, who might benefit from advanced therapy options.
 
The TEAM-HF trial will enroll up to 850 patients at 75 sites across the world. It will measure pulmonary artery pressures (PAP) using Abbott’s CardioMEMS HF system to identify heart failure patients with high mortality risk who could benefit from the HeartMate 3 left ventricular assist device (LVAD) earlier in their disease progression.
 
End-stage heart failure patients who need IV-administered medications to strengthen the heart’s blood pumping ability have poor outcomes, with median survival of nine months. Recommendations for treating these patients include advanced therapies like LVADs.
 
However, patients who don’t yet depend 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 first have investigators examine PAP data from subjects using CardioMEMS. The sensor is placed in the pulmonary artery in a minimally invasive, outpatient procedure and monitors pulmonary artery pressure changes over time. If pressures don’t reduce with guideline-directed therapy, TEAM-HF aims to prove such patients will benefit from advanced therapies.

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MORE INFO: Study Shows Abbott’s CardioMEMS Sensor Almost Halves Heart Failure Hospitalizations

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These patients will be randomized to receive either the HeartMate 3 LVAD 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.
 
The trial’s powered primary and secondary endpoints will be evaluated at two years, with long-term follow up through five years.
 
“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 Detroit-based Henry Ford Health, and one of the national co-principal investigators for the TEAM-HF trial. “Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym—TEAM-HF—and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey.”
 
“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,” added Keith Boettiger, VP of 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.”