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Acute Decompensated Heart Failure (ADHF)Phase 2/3CAESARNCT07023016

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure

A Phase 2/3 study testing Sacubitril / Valsartan and Ramipril (ACE-inhibitor) in people with Acute Decompensated Heart Failure (ADHF) and Chronic Kidney Disease (CKD), run by National Heart Institute, Egypt at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR < 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacubitril / Valsartan and Ramipril (ACE-inhibitor)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
2 sitesEgypt
Study dates
1 Nov 2023to 28 Feb 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

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

  • Acute decompensated heart failure (ADHF)
  • Left ventricular ejection fraction (LVEF) below 40%
  • Renal dysfunction; defined as eGFR of 30mL/min/1.73m2 to less than 60mL/min/1.73m2 in relation to the level of urinary albumin/creatinine ratio (uACR) based on the 2024 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines for the evaluation and management of CKD.
  • A minimum blood pressure (BP) ≥ 105/60 mmHg.
  • Independent of any inotropic or vasopressor support in the previous 24 hours before inclusion and randomization.
  • No more than 72 hours had passed since admission to the heart failure unit.
  • Patients should have had a New York Heart Association (NYHA) functional class II-IV, in addition to symptoms of volume overload at the time of presentation to the emergency room.

Who cannot join

  • Patients who were on sacubitril/valsartan or ACEI/ angiotensin receptor blocker (ARB) before inclusion in the previous 12 months.
  • Patients with AKI on presentation OR in the last 3 months OR had ≥ 2 hospital admissions in the last 12 months for AKI.
  • History of known or suspected hypersensitivity, contraindications, or intolerance to any of the study drugs including ACEI, ARB or sacubitril (neprilysin inhibitor).
  • Requirement for double treatment with both ACEI and ARB.
  • Serum potassium (K+) level ≥ 5.0 mmol/L at randomization.
  • A recent major adverse cardiovascular/cerebrovascular event within 1 month (acute coronary syndrome, stroke, transient ischemic attack, etc.).
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  • Patients with hemodynamically significant primary valvular lesion.
  • Known hepatic impairment with a model for end-stage liver disease (MELD) score >10. 23
  • History of malignancy of any organ system within the past year with a life expectancy < 1 year.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Cairo University Hospitals

    Cairo

  • National Heart Institute

    Cairo

Other trials in Egypt

About this study

Official title: Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure - CAESAR (a Randomized Controlled Trial)

Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR < 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease \& presenting with decompensated heart failure has not yet been explored fully.

Being tested
Sacubitril / Valsartan, Ramipril (ACE-inhibitor)
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.

  • Sacubitril / ValsartanDrug

    Patients will receive sacubitril/valsartan at an initial dose of 24/26 mg Bid.

  • Ramipril (ACE-inhibitor)Drug

    Patients will receive ramipril at an initial dose of 2.5 mg Bid.

Study groups in NCT07023016
Study groupRoleWhat they receive
Sacubitril / ValsartanExperimentalNot described
Receives: Drug: Sacubitril / Valsartan
RamiprilActive comparatorNot described
Receives: Drug: Ramipril (ACE-inhibitor)

What is being measured

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

  1. Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Number of patients in each group who develop worsening renal function throughout the study period.

    Defined as a 50% increase in the serum creatinine level (mg/dL) from baseline and/or a drop in eGFR by more than 25 ml/min/1.73m2.

    Measured: 12 weeks

  2. Number of events in each group for hyperkalemia throughout the study period.

    Defined as a rise in serum potassium level to ≥ 5.5 mEq/L .

    Measured: 12 weeks

  3. Number of events in each group for symptomatic hypotension throughout the study period.

    Defined as the subjective sense of dizziness or lightheadedness, blurred, or fading of vision, fainting, fatigue, difficulty concentrating and/or nausea in the presence of a BP of 90/60mmHg or lower.

    Measured: 12 weeks

  4. Number of events in each group for angioedema throughout the study period.

    Defined as a swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal tissues.

    Measured: 12 weeks

  5. Difference between uACR levels (gm/mg) in each group at 12 weeks post-randomization.

    Measured: 12 weeks

  6. Difference between NT-proBNP levels (pg/mL) in each group at 12 weeks post-randomization

    Measured: 12 weeks

  7. Difference between LVEF (%) of each group at 12 weeks post-randomization

    Measured: 12 weeks

Timeline

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

  1. First posted15 Jun 2025
  2. Study start1 Nov 2023
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023016
Sponsor's protocol ID
MD-464-2023
Acronym
CAESAR
Status last verified
Jun 2025
First submitted
8 Jun 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sacubitril / Valsartan and Ramipril (ACE-inhibitor) in people with Acute Decompensated Heart Failure (ADHF) and Chronic Kidney Disease (CKD), run by National Heart Institute, Egypt at 2 sites in Egypt.

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 7 inclusion and 9 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization. (time frame: 12 weeks). 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 NCT07023016.

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 13 Aug 2026.

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