NCT06463964

Brief Summary

Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the co-existence of acute cardiac and renal dysfunction, known as acute cardiorenal syndrome CRS, and its management have recieved great attention recently Various studies have employed different criteria to define and calssify AKI. According to Risk, Injury, and Failure; and Loss, and End-stage kidney disease RIFLE criteria formulated by the Acute Dialyisis Quality Initiative ADQI AKI can be divided into five stages; renal injury risk, renal impairment, renal failure, renal function loss, and end stage kidney disease

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 4, 2024

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER

    Change in serum creatinine in patients with acute decompensated heart failure in ER

    6 months

Study Arms (2)

Group I

( Patients with worsening ADHF)

Diagnostic Test: Serum Creatinine

Group II

(Patients with new (de novo ) ADHF)

Diagnostic Test: Serum Creatinine

Interventions

Serum CreatinineDIAGNOSTIC_TEST

Laborataries for prediction of AKi in patients with ADHF

Also known as: CBC, Estimated GFR, Lipid profile, Serum electrolytes, CKMB, Cardiac Troponin
Group IGroup II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aged \>18 Yrs Both Sexes Patients with ADHF

You may qualify if:

  • Aged \>18 Yrs Both Sexes Patients with ADHF

You may not qualify if:

  • Patients udnergoing maintenance renal replacment therapy (RRT) such as hemodialysis and peritoneal dialysis History of CKD Kdiney transplantation Undergoing opeartions within 1 week before and after AKI events Drug Toxicity Rheumatologic or auto immune disease Acute infection Diretic therapy of radio-opaque contrast media in the last 15 days History of aminoglycosides, metformin and nonsteroid anti inflammatory drugs in the last 7 days Thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Afsar B, Ortiz A, Covic A, Solak Y, Goldsmith D, Kanbay M. Focus on renal congestion in heart failure. Clin Kidney J. 2016 Feb;9(1):39-47. doi: 10.1093/ckj/sfv124. Epub 2015 Nov 29.

    PMID: 26798459BACKGROUND
  • Chahal RS, Chukwu CA, Kalra PR, Kalra PA. Heart failure and acute renal dysfunction in the cardiorenal syndrome. Clin Med (Lond). 2020 Mar;20(2):146-150. doi: 10.7861/clinmed.2019-0422.

    PMID: 32188648BACKGROUND
  • Chen JJ, Lee TH, Kuo G, Yen CL, Chen SW, Chu PH, Fan PC, Chien-Chia Wu V, Chang CH. Acute Kidney Disease After Acute Decompensated Heart Failure. Kidney Int Rep. 2022 Jan 3;7(3):526-536. doi: 10.1016/j.ekir.2021.12.033. eCollection 2022 Mar.

    PMID: 35257065BACKGROUND
  • Fuhrman DY, Stanski NL, Krawczeski CD, Greenberg JH, Arikan AAA, Basu RK, Goldstein SL, Gist KM; ADQI 26 workgroup. A proposed framework for advancing acute kidney injury risk stratification and diagnosis in children: a report from the 26th Acute Disease Quality Initiative (ADQI) conference. Pediatr Nephrol. 2024 Mar;39(3):929-939. doi: 10.1007/s00467-023-06133-3. Epub 2023 Sep 5.

    PMID: 37670082BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Magdy M Amin, Professor

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident- Department of Internal Medicine

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 18, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations