NCT06664073

Brief Summary

Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in emergency department acute heart failure patients in Egyptian population

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Oct 2024

Typical duration for all trials

Status
not yet 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 Progress51%
Oct 2024Oct 2027

First Submitted

Initial submission to the registry

October 27, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2027

Expected
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 27, 2024

Last Update Submit

October 27, 2024

Conditions

Keywords

Heart risk 6 scaleAcute heart failure

Outcome Measures

Primary Outcomes (1)

  • Detect the predictive value of the heart risk 6 scale

    -Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in the emergency department acute heart failure patients.

    1 month

Secondary Outcomes (1)

  • Describe the management and outcomes of ED patients with acute heart failure

    1

Study Arms (1)

Patients will be assessed by supervised cardiology residents in emergency department, within 24 hou

Patients will be assessed for standardized clinical variables by supervised cardiology residents in emergency department, within 24 hours from ED treatment. •Routine laboratory values will be collected, cardiac troponins and ECG.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute heart failure

You may qualify if:

  • patients who have appropriate symptoms (short-ness of breath or fatigue)(\<7 days duration); with clinical signs of fluid retention (pulmonary or peripheral) in the presence of an underlying abnormality of cardiac structure or function.
  • If in doubt, a beneficial response to treatment (eg, a brisk diuresis accompanied by improvement in breathlessness) will be considered.

You may not qualify if:

  • Patients who did not fit the definition of AHF or who were clearly too ill to be considered for discharge after 24 hours from ED:
  • \) resting oxygen saturation \<85% on room air
  • \) heart rate \>120 beats/min;
  • \) systolic blood pressure \<85 mm Hg;
  • \) confusion, disorientation, dementia;
  • \) primary presentation for ischemic chest pain requiring treatment or with acute ischemic ST-Tchanges on initial electrocardiogram (ECG);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Stiell IG, Clement CM, Brison RJ, Rowe BH, Borgundvaag B, Aaron SD, Lang E, Calder LA, Perry JJ, Forster AJ, Wells GA. A risk scoring system to identify emergency department patients with heart failure at high risk for serious adverse events. Acad Emerg Med. 2013 Jan;20(1):17-26. doi: 10.1111/acem.12056.

    PMID: 23570474BACKGROUND
  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PMID: 27206819BACKGROUND
  • Stiell IG, Perry JJ, Eagles D, Yadav K, Clement CM, McRae AD, Yan JW, Mielniczuk L, Rowe BH, Borgundvaag B, Dreyer J, Brown EL, Nemnom MJ, Taljaard M. The HEARTRISK6 Scale: Predicting Short-Term Serious Outcomes in Emergency Department Acute Heart Failure Patients. JACC Adv. 2024 May 24;3(7):100988. doi: 10.1016/j.jacadv.2024.100988. eCollection 2024 Jul.

    PMID: 39129980BACKGROUND

Central Study Contacts

Basma Mahrous Mohamed, Master student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 29, 2024

Study Start

October 27, 2024

Primary Completion

October 27, 2025

Study Completion (Estimated)

October 27, 2027

Last Updated

October 29, 2024

Record last verified: 2024-10