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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Cohort will be comprised of a minimum of 75 participatns with HFrEF and a minimum of 25 participants with HFmrEF/HFpEF. At each visit, presence of intolerances to GDMT will be sought and recorded. Medications will include those outlined by GDMT, including angiotensin receptor/neprilysin inhibitors (ARNI), angiotensin II receptor blockers (ARB), angiotensin converting enzyme inhibitors (ACEi), evidence based beta blockers (eBBB), aldosterone receptor antagonists (MRA), and sodium-glucose co-transporter 2 (SGLT2) inhibitors. | ||
| Research Patient Data Repository (RPDR) | Patients will be selected from those with available data following May of 2020 (after regulatory approval of SGLT2 inhibitors for treatment of HFrEF) or in the case of HFpEF following February 2022. |
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| Measure | Description | Time Frame |
|---|---|---|
| GDMT Administration for HF | Effect of GDMT Clinic versus Usual Care on administration of GDMT for HF. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanistic HF Outcomes | Effect of GDMT Clinic versus Usual Care on changes in mechanistic HF outcomes. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of GDMT Initiation | Assess tolerability of rapid-sequence initiation of GDMT in the GDMT Clinic | 12 weeks |
| Outcomes at 6 Months | Effect of GDMT Clinic versus Usual Care on incident cardiovascular outcomes during a 6 month follow up period. |
Inclusion Criteria:
Diagnosis of HF, including new onset disease
Established cardiovascular follow up at MGH
Receiving sub-optimal medical care defined as <50% target doses of GDMT agents
Age ≥18 years
For HFpEF:
Exclusion Criteria:
Planned referral to the Advanced HF program
Decompensated HF
End-stage kidney disease
Untreated severe valvular heart disease
Advanced HF
Life expectancy <12 months due to non-CV disease
Pericardial constriction
Hypertrophic cardiomyopathy
Unwillingness or inability to take GDMT
Pregnancy or breast feeding
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Ambulatory patients with NYHA Class I-IV HF, aged ≥18 years, directly referred to GDMT Clinic from cardiology clinics at MGH. A minimum of 75 patients with HFrEF will be included in the GDMT Clinic arm. Patients with improved EF will be included as HFrEF.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39387769 | Result | Spahillari A, Cohen LP, Lin C, Liu Y, Tringale A, Sheppard KE, Ko C, Khairnar R, Williamson KM, Wasfy JH, Scott NS, Paquette C, Greene SJ, Fonarow GC, Januzzi JL Jr. Efficacy, Safety and Mechanistic Impact of a Heart Failure Guideline-Directed Medical Therapy Clinic. JACC Heart Fail. 2025 Apr;13(4):554-568. doi: 10.1016/j.jchf.2024.08.017. Epub 2024 Oct 9. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A blood sample for circulating biomarkers is obtained at baseline and as part of routine follow up.
| 6 months |