Can a newer heart failure drug protect kidneys better than an older one?
NCT ID NCT07023016
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute decompensated heart failure (ADHF) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Higher domperidone doses under scrutiny for older kidney patients
- Device aims to ease heart strain by partially blocking veins
- Does dialysis strip the body of essential metals?
- Can a diabetes drug clear fluid from lungs in heart failure?
- Which dialysis method offers the best life and survival?
- Can big data unmask hidden clusters of cardiometabolic disease?