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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvi Liliek Wulandari

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ramipril

    Drug

    Ramipril administered either as 10 mg once daily or 5 mg twice daily for 30 days

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Once-Daily RamiprilExperimental treatment 1 intervention
Group B: Twice-Daily RamiprilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Plasma Renin Activity (PRA)

Change in plasma renin activity from baseline to day 30.

Time frame
30 days
2

Change in Malondialdehyde (MDA)

Change in plasma MDA levels as a biomarker of oxidative stress

Time frame
30 days
3

Change in Interleukin-6 (IL-6)

Change in serum IL-6 levels as a marker of systemic inflammation

Time frame
30 days
4

Change in Albuminuria

Change in albumin-creatinine ratio (ACR) from baseline to day 30

Time frame
30 days

Secondary outcomes

1

Change in Serum Creatinine

Change in serum creatinine concentration from baseline to day 30, measured by standard hospital laboratory methods

Time frame
30 days
2

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

Time frame
30 days
3

Change in Blood Pressure (Systolic and Diastolic)

Change in clinic-measured systolic and diastolic blood pressure from baseline to day 30

Time frame
30 days
4

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evi Liliek Wulandari

Lead sponsor

Universitas Sebelas Maret

Sponsor institution