Heart Failure
Conditions
Brief summary
There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.
Detailed description
To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide \[H-IDSN\]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).
Interventions
DRUGsacubitril/valsartan
Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.
Sponsors
Methodist Health System
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Self-identified as AA * NYHA class II-IV symptoms * Left ventricle EF \<40% * Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated. * Patient must have minimum of three months follow-up
Exclusion criteria
* Patients not meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite CV mortality or HF hospitalization | April 2017 to August 2020 | Composite CV mortality or HF hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CV mortality | April 2017 to August 2020 | Individual components |
| HF hospitalization | April 2017 to August 2020 | Individual components |
| All-cause mortality | April 2017 to August 2020 | Individual components |
| New atrial fibrillation | April 2017 to August 2020 | Individual components |
| Renal function decline | April 2017 to August 2020 | Individual components |
| Change in EF | April 2017 to August 2020 | Individual components |
| Change in NYHA classification | April 2017 to August 2020 | Individual components |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCrystal Brown, PharmD
Methodist Dallas Medical Center Pharmacy
Outcome results
None listed