Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure

Evi Liliek Wulandari

Status and phase: Enrolling; Phase 4

Conditions: Chronic Kidney Disease; Heart Failure With Reduced Ejection Fraction (HFrEF)

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT07259512

041/UN27.46/TA.04.19/KEP/EC/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Once-Daily Ramipril

Experimental group

Description:

Participants receive ramipril 10 mg once daily for 30 days

Treatment:

Drug: Ramipril

Twice-Daily Ramipril

Experimental group

Description:

Participants receive ramipril 5 mg twice daily for 30 days

Treatment:

Drug: Ramipril