About this trial
This study compares the effects of once-daily versus twice-daily ramipril dosing on renal function in chronic kidney disease (CKD) patients with heart failure with reduced ejection fraction (HFrEF). Outcomes include changes in plasma renin activity, malondialdehyde, interleukin-6, albuminuria, and cystatin C after 30 days of therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or Male with age >18 years old
Patients with a diagnosis of CKD stage 3-5 non-dialysis with low ejection fraction heart failure (ejection fraction < 40%)
Disqualifiers
Receiving hemodialysis therapy
History of intolerance to ACE inhibitors
Refractory hyperkalemia
Pregnancy
Trial design
Parallel
Treatments tested in this trial
Ramipril
DrugRamipril administered either as 10 mg once daily or 5 mg twice daily for 30 days
Treatment groups
Trial outcomes
Primary outcomes
Change in Plasma Renin Activity (PRA)
Change in plasma renin activity from baseline to day 30.
Change in Malondialdehyde (MDA)
Change in plasma MDA levels as a biomarker of oxidative stress
Change in Interleukin-6 (IL-6)
Change in serum IL-6 levels as a marker of systemic inflammation
Change in Albuminuria
Change in albumin-creatinine ratio (ACR) from baseline to day 30
Secondary outcomes
Change in Serum Creatinine
Change in serum creatinine concentration from baseline to day 30, measured by standard hospital laboratory methods
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) from baseline to day 30, calculated using the CKD-EPI equation
Change in Blood Pressure (Systolic and Diastolic)
Change in clinic-measured systolic and diastolic blood pressure from baseline to day 30
Incidence of Treatment-Related Adverse Events
Number and type of adverse events considered related to ramipril during 30 day treatment period (e.g. hyperkalemia), graded by severity
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Evi Liliek Wulandari
Lead sponsor
Universitas Sebelas Maret
Sponsor institution