Heart Failure
Conditions
Keywords
Medical therapy, Implementation, Cardiac remodeling
Brief summary
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).
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HF, including new onset disease * Established cardiovascular follow up at the hospital * Received sub-optimal medical care defined as \<50% target doses of GDMT agents * Left ventricular ejection fraction (LVEF) \<50%
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 * Inotropic support * Transplant or mechanical circulatory support (MCS) planned * Enrolled in hospice or palliative care * Life expectancy \<12 months due to non-cardiovascular (CV) disease * Pericardial constriction * Hypertrophic cardiomyopathy * Unwillingness or inability to take GDMT * Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up | Up to approximately 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change From Baseline in New York Heart Association (NYHA) Classification | Baseline and up to approximately 16 weeks | 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. |
| 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 | — |
| 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 | — |
| 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 | — |
| Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi) | Baseline and up to approximately 16 weeks | — |
Countries
United States
Outcome results
None listed