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Chronic Kidney DiseasePhase 4NCT07259512

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

A Phase 4 study testing Ramipril in people with Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Evi Liliek Wulandari at 1 site in Indonesia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramipril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteIndonesia
Study dates
30 Jun 2025to 31 Jan 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Evi L Wulandari, MD., Internist contact

(+62)821-3587-2749

evililiek@staff.uns.ac.id

Indonesia1 site, 1 recruiting

  • UNS Hospital

    Kartasura, Central Java

    Evi L Wulandari, MD., Internist, (+62)821-3587-2749, evililiek@staff.uns.ac.id

    Recruiting

Other trials in Indonesia

About this study

Official 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

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.

Read the 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.

Being tested
Ramipril
Keywords
Chronic Kidney Disease, HFrEF, Ramipril
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamiprilDrug

    Also called ACE inhibitor

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

Study groups in NCT07259512
Study groupRoleWhat they receive
Once-Daily RamiprilExperimentalParticipants receive ramipril 10 mg once daily for 30 days
Receives: Drug: Ramipril
Twice-Daily RamiprilExperimentalParticipants receive ramipril 5 mg twice daily for 30 days
Receives: Drug: Ramipril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Plasma Renin Activity (PRA)

    Change in plasma renin activity from baseline to day 30.

    Measured: 30 days

  2. Change in Malondialdehyde (MDA)

    Change in plasma MDA levels as a biomarker of oxidative stress

    Measured: 30 days

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

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

    Measured: 30 days

  4. Change in Albuminuria

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

    Measured: 30 days

  5. Change in Cystatin C

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

    Measured: 30 days

Secondary outcomes (4)

  1. Change in Serum Creatinine

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

    Measured: 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

    Measured: 30 days

  3. Change in Blood Pressure (Systolic and Diastolic)

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

    Measured: 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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start30 Jun 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07259512
Sponsor's protocol ID
041/UN27.46/TA.04.19/KEP/EC/20
Status last verified
Dec 2025
First submitted
20 Nov 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2020 Oct;98(4S):S1-S115. doi: 10.1016/j.kint.2020.06.019. No abstract available.

    PubMed 32998798

  • Ariton DM, Jimenez-Balado J, Maisterra O, Pujadas F, Soler MJ, Delgado P. Diabetes, Albuminuria and the Kidney-Brain Axis. J Clin Med. 2021 May 27;10(11):2364. doi: 10.3390/jcm10112364.

    PubMed 34072230

  • Kreiner FF, Kraaijenhof JM, von Herrath M, Hovingh GKK, von Scholten BJ. Interleukin 6 in diabetes, chronic kidney disease, and cardiovascular disease: mechanisms and therapeutic perspectives. Expert Rev Clin Immunol. 2022 Apr;18(4):377-389. doi: 10.1080/1744666X.2022.2045952. Epub 2022 Mar 1.

    PubMed 35212585

  • Jakopin E, Knehtl M, Hojs NV, Bevc S, Piko N, Hojs R, Ekart R. Treatment of acute kidney injury with continuous renal replacement therapy and cytokine adsorber (CytoSorb(R)) in critically ill patients with COVID-19. Ther Apher Dial. 2024 Dec;28(6):941-950. doi: 10.1111/1744-9987.14182. Epub 2024 Jul 3.

    PubMed 38958006

  • Nijst P, Verbrugge FH, Martens P, Bertrand PB, Dupont M, Francis GS, Tang WW, Mullens W. Plasma renin activity in patients with heart failure and reduced ejection fraction on optimal medical therapy. J Renin Angiotensin Aldosterone Syst. 2017 Jul-Sep;18(3):1470320317729919. doi: 10.1177/1470320317729919.

    PubMed 28875746

  • Arifiyanto, A. Y., Dwi Laksono, A., Chalidyanto, D., Taniasari, N., & Kusumaningtyas, W. (2021). Factors Related to the Prevalenceof Chronic Kidney Disease in Indonesia:An Ecological Study. Indian Journal of Forensic Medicine & Toxicology, 15(3), 1867-1873.

  • Tedeschi A, Agostoni P, Pezzuto B, Corra' U, Scrutinio D, La Gioia R, Raimondo R, Passantino A, Piepoli MF. Role of comorbidities in heart failure prognosis Part 2: Chronic kidney disease, elevated serum uric acid. Eur J Prev Cardiol. 2020 Dec;27(2_suppl):35-45. doi: 10.1177/2047487320957793.

    PubMed 33238740

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ramipril in people with Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Evi Liliek Wulandari at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evi L Wulandari, MD., Internist ((+62)821-3587-2749, evililiek@staff.uns.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Plasma Renin Activity (PRA) (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259512, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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