GOAL-HF-1
Research type
Research Study
Full title
Randomized, double-blind, multiple ascending dose, placebo-controlled, multi-center, safety, tolerability, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) phase 1b/2a clinical trial with AC01 in patients with heart failure with reduced ejection fraction (HFrEF)
IRAS ID
1005637
Contact name
Göran Westerberg
Contact email
Sponsor organisation
AnaCardio AB
Eudract number
2022-000813-15
Clinicaltrials.gov Identifier
Research summary
An investigational medication named AC01 is being tested for the treatment of a heart condition called heart failure.Heart failure is a condition in which the heart is not able to pump enough oxygen-rich blood around the body.This may make people feel tired, short of breath, and may make parts of the body swell.AC01 works by increasing hormones in the body which may potentially improve the pump function of the heart.AC01 is an investigational medication because its safety and how it works is still being researched.AC01 is being tested in patients with heart failure to find out if it is safe and if its effects are acceptable compared to placebo, and what potentially beneficial effects AC01 has on patients with heart failure.Patients will either receive AC01 or placebo (dummy pill) to allow a comparison to see the true effects of AC01.Neither patients nor the doctors and nurses will know which treatment is which.The treatment the patient receives will be decided by chance by a computer.AC01 or placebo will be taken as small tablets, by mouth, 2 times a day.This study consists of two parts: Part A will include up to 56 patients with heart failure, aged 18 years to 80 years and will last about 40 days, including an assessment period of up to 28 days, a treatment period of 7 days and a visit to check overall health at the end.Different doses of AC01 will be tested.Part B will include 40 to 60 patients with heart failure and will last about 63 days including an assessment period of up to 28 days and a treatment period of 28 days during which blood samples will be collected to assess the effects of the drug.There will also be a visit at the end to check overall health.In Part B, at least 2 different dose levels of AC01 will be tested (based on findings from Part A).All patients in this study will have a small device called an implantable cardioverter defibrillator, which will be placed in the chest to monitor the heartbeat.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0459
Date of REC Opinion
11 Aug 2022
REC opinion
Further Information Favourable Opinion