- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664073
Heart Risk 6 Scale in Emergency Department Acute Heart Failure Patients
The Predictive Value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in Emergency Department Acute Heart Failure Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Basma Mahrous Mohamed, Master student
- Phone Number: 01019534749 01019534749
- Email: mahrousbasma@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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:
- 1) resting oxygen saturation <85% on room air
- 2) heart rate >120 beats/min;
- 3) systolic blood pressure <85 mm Hg;
- 4) confusion, disorientation, dementia;
- 5) primary presentation for ischemic chest pain requiring treatment or with acute ischemic ST-Tchanges on initial electrocardiogram (ECG);
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detect the predictive value of the heart risk 6 scale
Time Frame: 1 month
|
-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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe the management and outcomes of ED patients with acute heart failure
Time Frame: 1
|
-Describe the management and outcomes of ED patients with acute heart failure, identify the various etiologies of this presentation, and characteristics and risk factors of this population.
|
1
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. Erratum In: Eur Heart J. 2018 Mar 7;39(10):860. doi: 10.1093/eurheartj/ehw383.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Heart Risk 6 scale in HF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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