Lokelma for RAASi in CKD HF and RCT (LiFT)
Research type
Research Study
Full title
Lokelma for maximisation of RAAS inhibition in CKD patients with Heart Failure; Randomised double blind placebo controlled Trial (LiFT)
IRAS ID
281626
Contact name
Debasish Banerjee
Contact email
Sponsor organisation
St George's University Hospitals NHS Foundation Trust
Eudract number
2020-002946-18
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Chronic Kidney disease (CKD) is common in patients with heart failure, 47% of all acute heart failure admissions in our hospital have chronic kidney disease. This group of patients suffer 2.4 times higher mortality compared to patients with heart failure. Although we have potential Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme inhibitor (ACEi), and Mineralcorticoid Receptor Antagonists (MRA), these drugs are underused in this patient group. This is due to the reluctance amongst physicians managing these patients to use medications which may increase the risk of a high potassium.
Lokelma has been shown to lower potassium concentrations in blood in non-CKD, CKD, and heart failure patients separately. This trial hopes to determine whether Lokelma is more effective than placebo in allowing maximization of dose of ARB, ACEi, and MRA in patients with CKD and heart failure, while maintaining potassium concentrations in blood at safe levels.
We will be recruiting eligible patients from Kidney failure-Heart failure clinic at St George’s Hospital and other heart failure clinics of St George’s and Kingston Hospital. To be eligible, patients must be > 18 years old, have both heart failure and kidney failure, with stable blood pressure, and not on or submaximal dose of ACEi/ARB and/or MRA. The duration is 10 weeks and a screening visit which will take place a week prior to the start of the study. Patients will meet researchers in clinic once every 2 weeks to obtain blood samples to measure potassium concentration in the blood and adjust their ARB, ACEi, MRA, and Lokelma where needed. The primary outcome after 10 weeks is to reach maximum ARB/ACEi and MRA dosage with a safe blood potassium level.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0227
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion