Chronic Kidney Disease, Heart Failure With Reduced Ejection Fraction (HFrEF)
Conditions
Keywords
Chronic Kidney Disease, HFrEF, Ramipril
Brief summary
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.
Detailed description
Chronic kidney disease (CKD) frequently coexists with heart failure with reduced ejection fraction (HFrEF), characterized by neurohormonal activation, inflammation, oxidative stress, and progressive renal deterioration. Activation of the renin-angiotensin-aldosterone system (RAAS) contributes significantly to both renal and cardiac dysfunction. Ramipril, an ACE inhibitor, is widely recommended for CKD with albuminuria and HFrEF. However, discrepancies exist in guidelines regarding once-daily versus twice-daily administration. These differences may influence RAAS suppression effectiveness and patient adherence. This randomized, double-blind, parallel assignment clinical trial investigates the impact of once-daily (10 mg every 24 hours) versus twice-daily (5 mg every 12 hours) ramipril dosing on renal biomarkers in CKD patients with HFrEF. Outcomes include plasma renin activity (PRA), malondialdehyde (MDA), interleukin-6 (IL-6), albuminuria, and cystatin C measured over a 30-day treatment period. The study aims to provide scientific evidence to support optimal ramipril dosing strategies that improve renal outcomes among patients with CKD and reduced ejection fraction heart failure.
Interventions
DRUGRamipril
Ramipril administered either as 10 mg once daily or 5 mg twice daily for 30 days
Sponsors
Evi Liliek Wulandari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Participants are randomly assigned in parallel to one of two treatment groups: once-daily ramipril (10 mg every 24 hours) or twice-daily ramipril (5 mg every 12 hours). Each participant remains in the same assigned arm for the entire 30-day treatment period, and outcomes are assessed at baseline and day 30.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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%)
Exclusion criteria
* Receiving hemodialysis therapy * History of intolerance to ACE inhibitors * Refractory hyperkalemia * Pregnancy * History of angioedema to ACE inhibitors * Receiving sacubitril-valsartan therapy * Receiving ARB therapy * Hypotension with blood pressure \<90/60, or patients in shock.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cystatin C | 30 days | Change in serum cystatin C levels as a marker of glomerular filtration |
| Change in Plasma Renin Activity (PRA) | 30 days | Change in plasma renin activity from baseline to day 30. |
| Change in Malondialdehyde (MDA) | 30 days | Change in plasma MDA levels as a biomarker of oxidative stress |
| Change in Interleukin-6 (IL-6) | 30 days | Change in serum IL-6 levels as a marker of systemic inflammation |
| Change in Albuminuria | 30 days | Change in albumin-creatinine ratio (ACR) from baseline to day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) | 30 days | 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) | 30 days | Change in clinic-measured systolic and diastolic blood pressure from baseline to day 30 |
| Incidence of Treatment-Related Adverse Events | 30 days | Number and type of adverse events considered related to ramipril during 30 day treatment period (e.g. hyperkalemia), graded by severity |
| Change in Serum Creatinine | 30 days | Change in serum creatinine concentration from baseline to day 30, measured by standard hospital laboratory methods |
Countries
Indonesia
Contacts
Primary ContactEvi L Wulandari, MD., Internist
Outcome results
None listed