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The aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). For the comparator arm, patients in the GDMT clinic were matched to data of patients contained within in the MGH Research Patient Data Repository (RPDR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDMT Clinic | Patients with HF with an abnormal ejection fraction (EF) who were referred to the GDMT clinic and underwent rapid guideline-recommended medication titration. | ||
| Usual Care (RPRD) | Patients from the MGH RPRD receiving care since the 2022 United States HF guideline update who were matched in a 2:1 fashion to GDMT clinic patients. Matching was based on age, sex, race, duration of HF, ischemic heart disease, diabetes mellitus, atrial fibrillation and baseline EF. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up | Class I GDMT drugs included angiotensin receptor/neprilysin inhibitor (ARNI), evidence-based beta blocker (eBBB), mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter-2 inhibitor (SGLT2i) or renin angiotensin system inhibitor (RASi), eBBB, MRA, SGLT2i. | Up to approximately 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up | Up to approximately 16 weeks | |
| Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline | Baseline and up to approximately 16 weeks |
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Inclusion criteria:
Exclusion criteria:
Planned referral to the Advanced HF program
Decompensated HF
End-stage kidney disease
o glomerular filtration rate (GFR) <15 mL/min/1.73m^2 or on renal replacement therapy
Untreated severe valvular heart disease
Advanced HF
Life expectancy <12 months due to non-cardiovascular (CV) disease
Pericardial constriction
Hypertrophic cardiomyopathy
Unwillingness or inability to take GDMT
Pregnancy or breast feeding
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This was a retrospective, non-interventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change From Baseline in New York Heart Association (NYHA) Classification | The NYHA classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity: Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Class IV - Unable to carry out any physical activity without symptoms of HF, or symptoms of HF at rest. | Baseline and up to approximately 16 weeks |
| Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration | Baseline and up to approximately 16 weeks |
| Change From Baseline in Echocardiography Measurement: LVEF | Baseline and up to approximately 16 weeks |
| Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi) | Baseline and up to approximately 16 weeks |
| Change From Baseline in Echocardiography Measurement: Left Ventricular End-Systolic Volume Index (LVESVi) | Baseline and up to approximately 16 weeks |
| Change From Baseline in Echocardiography Measurement: Left Atrial Volume Index (LAVi) | Baseline and up to approximately 16 weeks |
| Change From Baseline in Echocardiography Measurement: Left Ventricular Mass Index (LVMi) | Baseline and up to approximately 16 weeks |