Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT06700213
The TEAM-MGH study will formerly evaluate impact of the GDMT Clinic versus matched usual care patients on the proportion of GDMT administration over a 12 week period in approximately 300 total patients with HF across the spectrum of LVEF (with a minimum of 150 with HFrEF). The study will also assess impact of the GDMT Clinic on health status, functional capacity, biomarker profiles, cardiac remodeling and cardiovascular events.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
The lack of adherence to Goal-Directed Medical Therapy (GDMT) is a major problem in modern HF care. Despite advances in therapies for those with HF along with well-articulated goals for achieving guideline-directed medical therapy (GDMT) for affected individuals, the treatment of persons with HF lags behind current recommended guideline approaches, with 30% of ambulatory patients with HFrEF not being prescribed angiotensin receptor/neprilysin inhibitors (ARNI), angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), or evidence based beta blockers (eBBB) and the majority not receiving target doses of these medications despite lack of medical contraindications. The reasons for gaps in care include hesitancy to change medical programs in ostensibly stable patients, concerns about risk of drug intolerances, worries about drug costs, as well as uncertainty about benefits. Additionally, complexity of medical therapy, rapid evolution in the currently recommended therapeutic options, and challenges in care coordination also result in missed treatment opportunities. Given that most individuals with HF are cared for by specialists other than those trained in advanced HF therapies, this intersection of increasing complexity of care results in substantial gaps in care. The proposed research is to study impact of the GDMT clinic for patients across the spectrum of HF.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 weeks
Effect of GDMT Clinic versus Usual Care on administration of GDMT for HF.
Time frame: 12 weeks
Effect of GDMT Clinic versus Usual Care on changes in mechanistic HF outcomes.
Time frame: 12 weeks
Assess tolerability of rapid-sequence initiation of GDMT in the GDMT Clinic
Time frame: 6 months
Effect of GDMT Clinic versus Usual Care on incident cardiovascular outcomes during a 6 month follow up period.
Massachusetts General Hospital
Other
Acronym: TEAM-MGH
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