Acute Heart Failure Phase III Clinical Trial Designed To Assess Early Treatment On Cardiovascular Mortality And Symptoms Initiated

Date: Feb-13-2013Cardiorentis has initiated the first-ever acute heart failure (AHF) Phase III trial to be specifically designed to assess the effect of early treatment on cardiovascular mortality. TRUE-AHF (TRial of Ularitide's Efficacy and safety in patients with Acute Heart Failure) aims to show that early treatment with intravenous (IV) ularitide may reduce AHF symptoms in the short-term and cardiovascular mortality in the long-term. Health authorities have agreed with the designation of cardiovascular mortality as a primary efficacy endpoint, and patient enrolment is already underway in the US and Europe.

Heart failure is a significant public healthcare concern, with an overall population
prevalence of approximately one to three per cent, rising to approximately 10 per cent in
the very elderly. AHF is one of the most common reasons for unscheduled hospitalisation of
people over the age of 65 years.[i] AHF patients are at a markedly increased risk of
rehospitalisation within three months of their first episode and experience mortality
rates five-times greater than that of patients following a heart attack.[ii],[iii]

"The TRUE-AHF is a landmark study. We believe that early decompression of the dilated
heart can reduce myocardial injury in patients with acutely decompensated heart failure,"
commented Milton Packer, M.D., chair of the trial, Professor and Chair, Department of
Clinical Sciences, University of Texas Southwestern Medical Center. He continued, "If
decompression produced by a 48-hour infusion of ularitide can prevent significant
myocardial damage during this vulnerable period, then we are likely to see a reduction in
cardiovascular mortality over the following months and years."

TRUE-AHF is designed to build on the growing body of evidence that suggests patients
suffering from AHF should be treated as early as possible. Heart failure experts,
cardiologists and emergency physicians are working hand-in-hand to ensure an early
enrolment of patients into the trial (within the first hours after presentation to the
hospital). The trial is evaluating the following endpoints:
A composite score that assesses the symptoms and clinical course of
     patients during the 48-hour infusion of ularitide.
Cardiovascular mortality following randomisation for the entire duration of
     the trial

"We have been in close discussions with the health authorities to achieve the most
robust study design for TRUE-AHF. We wanted the study design to reflect our belief that
ularitide could provide symptom improvement and a reduction in cardiovascular mortality,
which are both crucial measures for new therapies being investigated for the treatment of
AHF. Following promising results in previous clinical trials SIRIUS I and II, we are
confident ularitide will provide clinicians with a much-needed addition to their AHF
treatment armamentarium," said Elmar Schnee, CEO Chairman at Cardiorentis Ltd. "We are
also encouraged that such a highly regarded group of cardiologists and emergency
physicians are working in partnership with us on the clinical programme," he added.

Approximately 190 centres across the US, Europe, Canada and Latin America will be
involved in the TRUE-AHF trial, and approximately 2,152 patients with AHF will be
randomised to receive placebo or ularitide for 48 hours in addition to standard care.

About Ularitide

Ularitide is an advanced natriuretic peptide in Phase III development as an
intravenous (IV) infusion treatment for acute heart failure (AHF). Ularitide is the
chemically synthesized form of urodilatin - a human, natriuretic peptide that is produced
in the kidneys and induces excretion of sodium into the urine (natriuresis) and increased
urine production (diuresis) to regulate fluid balance and sodium haemostasis. Ularitide
induces natriuresis and diuresis by binding to specific natriuretic peptide receptors
(NPR-A, NPR-B and other natriuretic peptide receptors), thereby increasing intracellular
cyclic guanosine monophosphate (cGMP) helping to relax smooth muscle tissues, leading to
vasodilation and increased blood flow.

About AHF

Heart failure is a growing problem worldwide. More than 23 million people around the
world are affected.[iv],[v] AHF can be defined as the sudden or gradual onset of the signs
or symptoms of heart failure resulting in a need for urgent therapy or hospitalisation.[vi
] It is a life-threatening condition which requires immediate medical attention. Signs and
symptoms of AHF include extreme fatigue and shortness of breath, worsening kidney
function, severe swelling, sudden weight gain and a distended jugular vein along the side
of the neck.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.