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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

NCT07023016 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2025-06-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Sacubitril / Valsartan

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

DRUG

Ramipril (ACE-inhibitor)

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

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • National Heart Institute, Egypt

    lead OTHER_GOV

Principal Investigators

  • Hesham Salah Eldin Taha, MD · Cairo University

  • Omar Younis, Msc · National Heart Institiute, Cairo - Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023016 on ClinicalTrials.gov