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NCT Number: NCT07259512

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Failure With Reduced Ejection Fraction (HFrEF) Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNS Hospital

Kartasura, Central Java, Indonesia

Location status: Recruiting

Location contact

Evi L Wulandari, MD., Internist

CONTACT

[email protected]

(+62)821-3587-2749

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril

Drug

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

Other names: ACE inhibitor

Primary outcomes

  1. Change in Plasma Renin Activity (PRA)

    Time frame: 30 days

    Change in plasma renin activity from baseline to day 30.

  2. Change in Malondialdehyde (MDA)

    Time frame: 30 days

    Change in plasma MDA levels as a biomarker of oxidative stress

  3. Change in Interleukin-6 (IL-6)

    Time frame: 30 days

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

  4. Change in Albuminuria

    Time frame: 30 days

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

  5. Change in Cystatin C

    Time frame: 30 days

    Change in serum cystatin C levels as a marker of glomerular filtration

Secondary outcomes

  1. Change in Serum Creatinine

    Time frame: 30 days

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

  2. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 30 days

    Change in estimated glomerular filtration rate (eGFR) from baseline to day 30, calculated using the CKD-EPI equation

  3. Change in Blood Pressure (Systolic and Diastolic)

    Time frame: 30 days

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

  4. Incidence of Treatment-Related Adverse Events

    Time frame: 30 days

    Number and type of adverse events considered related to ramipril during 30 day treatment period (e.g. hyperkalemia), graded by severity

Study contacts

Contact information is provided by the study sponsor or research team.

Evi L Wulandari, MD., Internist

CONTACT

[email protected]

(+62)821-3587-2749

Sponsors and collaborators

Lead sponsor

Evi Liliek Wulandari

Other

Registry information

Official study title

Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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