Comparison of AZD9977 with Spironolactone in Heart Failure
Research type
Research Study
Full title
A Phase I, Open Label, Randomized, Parallel Group, Multicentre study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] during 28 days in Patients with HFmrEF or HFpEF and eGFR in the range of ≥40 and ≤70 mL/min/1.73m2
IRAS ID
250366
Contact name
Iain Squire
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-000707-16
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
: Heart failure (HF) is an important medical condition that occurs when the function of the heart is inadequate to maintain adequate blood supply to the body. Approximately half of patients with HF have normal or only mildly reduced pumping function of the heart, whilst the other half have moderate or severely reduced heart pumping function. Whilst there are several drugs proven to be of benefit for patients with moderate or severely reduced heart pumping function, there are currently no medications that have been shown to improve the outcome for patients with normal or mildly reduced pumping function. AZD9977 is a drug being developed as a potential treatment for patients with HF with normal or mildly reduced heart pump function. The purpose of this study is to compare the effects of AZD9977 with spironolactone on serum potassium levels in heart failure patients over a 28-day dosing period. Spironolactone is a licensed medication, with a similar mechanism of action to AZD9977, already used in the treatment of patients with HF. The safety and tolerability of AZD9977 will also be evaluated. As many patients with HF also have reduced kidney function, adult (aged 18 years or older) patients with HF and mild-moderate kidney impairment (estimated glomerular filtration rate 40-70mL/min/1.73m2) will be invited to participate in this study. Patients will be asked to attend 6 study visits over the course of 4 weeks as well as a follow-up visit approximately 1 week after the study medication is stopped. Blood potassium levels and kidney function will be closely monitored, and other measurements including blood tests, urine tests and a heart scan (echocardiogram) will be performed during the study. Both men, and women of non-childbearing potential are eligible for the study provided the study eligibility criteria defined in the full study protocol are met.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0296
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion