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Can a newer heart failure drug protect kidneys better than an older one?

NCT ID NCT07023016

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether sacubitril/valsartan, a newer heart failure medication, is safer and more effective for the kidneys than ramipril, an older ACE inhibitor, in people hospitalized with acute decompensated heart failure who also have chronic kidney disease. About 515 participants with reduced heart pumping function and moderate kidney impairment will receive one of the two drugs. The main goal is to compare changes in kidney function (eGFR) after 12 weeks, with additional monitoring for worsening kidney function and high potassium levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacubitril/valsartan (a combination drug) compared to ramipril (an ACE inhibitor)
What this could lead to
If sacubitril/valsartan proves safer and more effective for the kidneys, it could become a preferred treatment for heart failure patients with chronic kidney disease.
What could go wrong
This is a mid-stage trial, and results may not confirm an advantage. Risks include worsening kidney function, high potassium levels, and low blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

515 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All the following should be met: * 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. Exclusion Criteria: * 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.). * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cairo University Hospitals

    Cairo, Egypt

  • National Heart Institute

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.