Krister Lindmark

Background Heart failure (HF) is a common disease with high mortality and morbidity especially in combination with severe chronic kidney disease (CKD). Virtually all major studies in HF exclude patients with  severe CKD. Eplerenone is one of the main therapies in HF.Aim The overall aim is to build a research network to study HF therapies in patients with HF in combination with severe CKD. The main trial is a randomized open label trial of eplerenone vs usual care. The pilot study will lay the foundation for the first trial and to evaluate the feasibility, safety and efficacy of using eplerenone in patients with HF with reduced ejection fraction (EF) in combination with severe CKD.MethodsInclusion and exclusion criteria for both the main trial and pilot study:HF with EF≤40% in combination with estimated glomerular filtration rate &lt

30 ml/min/1.73mPatients with ongoing or planned dialysis, hypotension and hyperkalemia will be excludedDesignMain trial - Open label randomized study with major adverse renal and cardiac events as primary endpointPilot study - N=40. Open label ABA-design (baseline, intervention, withdrawal). Two observational periods are chosen as the patient group has a high risk of clinical events. 12 week observation, 12 week treatment and 12 week washout. Feasibility and safety are the key endpoints and efficacy endpoints are exploratory.The pilot study will help to develop eCRF, safety protocols and help to estimate recruitment potential for the main trial.