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Heart failure, or HF, is a condition that exists when the heart cannot pump blood to the body as quickly as needed. Blood returning to the heart faster than the heart can eject it congests the system behind it. Decreased blood flow to organs, such as the kidneys, causes the body to retain more fluid, which further complicates the problem. As a result, HF can often cause damage to the kidneys and other organs, which in turn can worsen the condition of the heart.
Acutely Decompensated Heart Failure (ADHF)
ADHF is an acute exacerbation of heart failure. Patients with heart failure are treated with a combination of drugs in an attempt to improve cardiac output and reverse fluid overload. Diuretics, such as furosemide, are used as a first-line treatment to relieve the symptoms of ADHF patients by helping to remove excess fluid from the body, which then helps to increase cardiac output. However, some studies have correlated high doses of intravenous (i.v.) furosemide, a diuretic, with a decreased kidney function and some patients can become resistant to the effects of furosemide. Second-line treatments are often palliative, and can come at the cost of an increased mortality rate. Despite aggressive therapy, 1 in 3 patients die of the disease within a year of diagnosis, reflecting a substantial need for novel treatments.
Post Acute Indication
There are over 1.2 million admissions for ADHF per year in the United States according to the American Heart Association. Within 90 days following admission for ADHF (the post-acute period), approximately 40% of patients return to the hospital. Post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms.
In multiple clinical trials in both acute and chronic heart failure patients, a short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters. Nile believes that the continuous and extended infusion of cenderitide through a subcutaneous pump will provide patients with sustained symptomatic relief in the outpatient setting that could contribute to a reduction in post-acute hospitalizations and persistent improvement in cardio-renal functions.
Cenderitide is expected to improve 90 day post-acute re-hospitalization through:
- Prolonged reduction of wedge pressure and blood pressure
- Additional diuretic and natriuretic effects on top of standard oral diuretics
- Improved medication compliance with a continuous subcutaneous pump delivery
- Possible prevention of the progression of maladaptive ventricular hypertrophy
- Suppression of cardiac fibroblast proliferation and a reduction in scarring
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