NCT06447467

Brief Summary

Around 26 million people suffer from heart failure (HF) globally, and the prevalence is increasing with an increasing longevity, prevalence of risk factors, and improved survival in patients with cardiovascular diseases In Egypt, HF is the primary cause of hospitalization among patients aged \> 65 years . Hospitalization for HF is associated with a high mortality and rate of re-hospitalization . Around 75% patients with HF have ≥ 1 comorbidity, and these comorbidities make overall clinical outcomes worse . In a recent meta-analysis, patients with diabetes mellitus (DM) were suggested to have a two-fold increase in the risk of HF . DM is present in \~ 35% patients hospitalized with acute HF . Multiple factors such as ischemia, hypertension, and extracellular fluid volume expansion are involved in the pathogenesis of HF in DM.

Trial Health

57
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
recruiting

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
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 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 20, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 3, 2024

Last Update Submit

June 17, 2024

Conditions

Acute Heart FailureDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Pro BNP level

    A pro BNP test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

    6 months

Study Arms (2)

Diabetic patients

Diabetic patients

Diagnostic Test: pro BNP

Non Diabetic patients

Non Diabetic patients

Diagnostic Test: pro BNP

Interventions

pro BNPDIAGNOSTIC_TEST

Test is mainly used to help diagnose or rule out heart failure in a person who is having symptoms

Diabetic patientsNon Diabetic patients

Eligibility Criteria

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

* Aged 18 years old or older . * Admitted to the Coronary Care Unit with acute HF. * Patients with new onset heart failure. * Decompensated chronic HF.

You may qualify if:

  • Aged 18 years old or older .
  • Admitted to the Coronary Care Unit with acute HF.
  • Patients with new onset heart failure.
  • Decompensated chronic HF.

You may not qualify if:

  • Aged under 18 years old.
  • Patients with chronic HF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.

    PMID: 21060326BACKGROUND

  • Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

    PMID: 19896746BACKGROUND

  • Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

    PMID: 24491689BACKGROUND

  • Cook SA, Varela-Carver A, Mongillo M, Kleinert C, Khan MT, Leccisotti L, Strickland N, Matsui T, Das S, Rosenzweig A, Punjabi P, Camici PG. Abnormal myocardial insulin signalling in type 2 diabetes and left-ventricular dysfunction. Eur Heart J. 2010 Jan;31(1):100-11. doi: 10.1093/eurheartj/ehp396. Epub 2009 Oct 1.

    PMID: 19797329BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Magdy M Amin, Professor

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina M Thabet, Resident

CONTACT

01018318271menamonir@med.sohag.edu.eg

Ali T Ali, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Internal medicine departement Sohag Universirty Hospital

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

EG(1)