TRUE AHF ULA01
Research type
Research Study
Full title
Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering from Acute Decompensated Heart Failure [TRUE-AHF]
IRAS ID
169257
Contact name
Chim Lang
Contact email
Sponsor organisation
Cardiorentis Ltd
Eudract number
2010-024249-59
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Congestive heart failure (CHF) is a significant public health care concern.
CHF is a clinical syndrome characteriesd by a rise in cardiac pressure and other symptoms which result in fluid retention and narrowing of veins.
Acute decompensated heart failure (ADHF) is characterized by a rapid change in the signs and symptoms of HF resulting in a need for urgent intervention. The typical signs of ADHF are shortness of breath and lower extremity swelling. ADHF can also cause pulmonary oedema (swelling) and shock to the heart.
ADHF is the most common reason patients end up in hospital, over the age of 65.
ADHF patients are at a marked increase of being rehospitalised within 3 months and experience 5 x higher death rate than those following a heart attack.
Treatment for ADHF hasnt changed meaningfully for over 10 years, and the treatments that are available can be associated with side effects that may contribute to the death rate.
Therefore there is an unmet need for new therapeutic approaches of ADHF that can demonstrate improved clinical status without adversely affecting patient outcomes in the long run.
This study is exploring a novel treatment for ADHF – ularitide.
Ularitide is a chemically synthesised analogue of urodilatin (a naturally occurring peptide in humans which naturally helps veins to dilate). Ularitide is more stable than urodilatin however, due to 4 additional amino acids at the N terminus, can remain in the body longer to have more of an effect.
Patients hospitalised with ADHF will be approached about the study and if they consent they will be screened for study participation.
Patients entering the study will then either be given the new study drug (ularitide), or a placebo.
The study is made up of 4 phases; pre dose, treatment, post treatment and post study follow up. The pre dose phase lasts for up to 12hours 15 mins, the treatment phase lasts for 48 hours, the post treatment phase lasts for up to 180 days and the post study follow up phase will continue every 90 days until the study ends.
Patients will have to give blood samples, have ECGs and an Xray as well as answer some short questionnaires.
The study is to investigate the effect of the study drug on ADHF and also to see if it has any effect on patients cardiovascular rehospitalisation
The purpose of this study is to evaluate the efficacy of ularitide and its effects on the recovery of the patients.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0053
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion