NCT06491628

Brief Summary

The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients

Trial Health

43
At Risk

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 Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 1, 2024

Last Update Submit

July 8, 2024

Conditions

Keywords

LFTs, AHF

Outcome Measures

Primary Outcomes (1)

  • Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals

    assessment the LFTs abnormalities and factors mediating hepatic impairment in patients with AHF

    baseline

Secondary Outcomes (1)

  • Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals

    1 year

Study Arms (5)

Acute decompensated heart failure (de novo or as decompensation of chronic heart failure)

This umbrella term includes patients presenting forthe first time with typical symptoms and signs of heart failure(de novo AHF) and also those with worsening of their pre-existing cardiomyopathy (acute decompensated heart failure).

Behavioral: Avoiding the risk factors

Pulmonary edema

It's the real clinical presentation of AHF, typically, signs and symptoms develope rapidly and patients demonstrate severe respiratory distress with tachypnea, orthopnea and pulmonary congestion

Behavioral: Avoiding the risk factors

Hypertensive acute heart failure

the condition is associated with elevated blood pressure with accompanying dyspnea. orthopnea and pulmonary congestion, often in patients with relatively preserved left ventricle ejection fraction

Behavioral: Avoiding the risk factors

cardiogenic shock

severe peripheral hypoperfusion wih subsequent end organs damage,typically it's associated with low blood pressure and low urine output

Behavioral: Avoiding the risk factors

Acute coronary syndrome complicated by heart failure

characterized by complex structural, hemodynamic and neurohormonal interaction need urgent referral for coronary intervention poor outcome

Behavioral: Avoiding the risk factors

Interventions

Exercise, Salt and lipid reduction in diet, smoking cessation

Acute coronary syndrome complicated by heart failureAcute decompensated heart failure (de novo or as decompensation of chronic heart failure)Hypertensive acute heart failurePulmonary edemacardiogenic shock

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients aged 18 yrs or older presenting with AHF

You may qualify if:

  • patients aged 18 yrs or older presenting with AHF

You may not qualify if:

  • Congenital heart disease
  • acute and chronic liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hamdy Saad

    Sohag University

    STUDY CHAIR
  • Haitham Mohammad

    Sohag University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations