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

COMPLETEDPHASE2/PHASE3

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

NCT07023016•National Heart Institute, Egypt

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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) prior to inclusion.
•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.

Locations (2)

Cairo University Hospitals

Cairo, Egypt

National Heart Institute

Cairo, Egypt

Key Dates

Start Date

November 1, 2023

Primary Completion Date

February 28, 2025

Completion Date

February 28, 2025

Last Updated

June 22, 2025

Enrollment

515

ACTUAL participants

Conditions

Acute Decompensated Heart Failure (ADHF)Chronic Kidney Disease (CKD)

Interventions

Sacubitril / Valsartan

DRUG

Ramipril (ACE-inhibitor)

DRUG

Comparison of the Effectiveness of Different Diuretic Therapies in the Management of Acute Heart Failure

NCT07464249

Acute Decompensated Heart Failure (ADHF)

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TERMINATEDPHASE3

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

NCT04064827

Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Comparison of the Effectiveness of Different Diuretic Therapies in the Management of Acute Heart Failure

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Domperidone and the Risk of Serious Adverse Events

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