Heart failure is a debilitating and potentially life-threatening condition where the heart is unable to pump enough blood around the body. Symptoms of fatigue, shortness of breath, and fluid retention can weaken the heart or make it stiff, significantly diminishing its ability to fill normally or effectively distribute blood. According to the American Heart Association, approximately five million people experience heart failure in the United States and more than half a million new cases are diagnosed annually in this country.
Heart failure affects both quality of life and lifespan. This debilitating ailment is now the most common diagnosis in Medicare patients and accounts for 55,000 deaths annually. Patients experiencing an acute heart failure episode have to be rushed to the hospital for treatment. Although it’s a diagnosis that carries a poor prognosis, it’s one that is improved and enhanced by medical and device therapy, and in some cases by heart transplantation.
A variety of drugs and devices are now used by doctors to help patients with heart failure feel better, but half of those hospitalized don’t survive longer than five years. Cardiologists may soon have a new weapon in their heart failure armamentarium that can relieve patients’ symptoms and protect their vital organs against damage during an acute heart failure episode.
Serelaxin, a synthetic version of the naturally occurring hormone, human relaxin-2, which is widely associated with pregnancy, has proven that it can improve acute heart failure symptoms after being infused over a 48-hour period in the hospital following a heart failure episode or a heart attack.
In women, relaxin helps loosen tissues in the reproductive organs and pelvic ligaments to help prepare for childbirth. The hormone also relaxes blood vessels, allowing them to expand. During pregnancy, this allows more blood to reach the placenta and kidneys without raising blood pressure.
In people with heart failure, the chemically engineered form of relaxin increases blood flow throughout the body, which helps a poorly functioning heart to be more effective. Relaxin is also an anti-inflammatory. Inflammation associated with heart failure can damage the kidneys, liver, and heart, but serelaxin appears to help prevent this from occurring.
Currently, 25% of all patients admitted to the hospital with acute heart failure die within a year of their admission. After Phase III study results from an international, double-blind, placebo-controlled trial reported a reduction in death rates by 37% in patients with acute heart failure six months following treatment for an acute episode compared to those who received standard therapy, the Food and Drug Administration (FDA) gave the investigational heart drug “breakthrough status” in 2013. This increases its prospect for faster FDA approval.
Once approved, serelaxin, the first in a new class of drugs that acts through a mechanism in the heart and kidneys, will become the first treatment breakthrough for acute heart failure in two decades. In clinical trials of people hospitalized with new onset of sudden heart failure, serelaxin also significantly improved shortness of breath, one of the most frightening and persistent symptoms of the disease. It also reduced organ damage caused by reduced blood flow, protected the kidneys and liver, and help resolve fluid buildup in the lungs more quickly than other therapies.
Where Are They Now
This drug was denied FDA approval in 2014 due to a lack of evidence to prove efficacy, and the advisory board is awaiting Phase III clinical trial data to make its next decision. The data release was expected in 2016, but was delayed until mid-2017. The Phase III trial showed that short-term intravenous infusion of the drug did not improve outcomes when compared with placebo.