Acute Heart Failure (AHF)NCT06664073
Heart Risk 6 Scale in Emergency Department Acute Heart Failure Patients
An observational study of Acute Heart Failure (AHF), run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Heart Failure (AHF)
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2024to 27 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute heart failure
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Predictive Value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in Emergency Department Acute Heart Failure Patients
Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in emergency department acute heart failure patients in Egyptian population
Read the detailed description
Recently, the heartrisk6 scale was introduced to predict the short-term serious outcomes in emergency department acute heart failure patients. It was created from 3 cohorts from American and Canadian population. Since the Egyptian population differ from the American and Canadian population regarding the age at presentation with cardiovascular disease, risk factors and etiology of the acute heart failure, we sought to detect the applicability of this score on our population.
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Heart risk 6 scale, Acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Describe the management and outcomes of ED patients with acute heart failure
-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.
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start27 Oct 2024 (estimated)
- Primary completion27 Oct 2025 (estimated)
- Study completion27 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mahrous Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664073
- Sponsor's protocol ID
- Heart Risk 6 scale in HF
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27206819Stiell 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.
PubMed 23570474Stiell 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.
PubMed 39129980
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in Emergency Department Acute Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06664073
- Acronym / sponsor ID
- Heart Risk 6 scale in HF
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Heart risk 6 scale, Acute heart failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Oct 2024 (estimated)
- Primary completion
- 27 Oct 2025 (estimated)
- Study completion
- 27 Oct 2027 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in emergency department acute heart failure patients in Egyptian population
Detailed description
Recently, the heartrisk6 scale was introduced to predict the short-term serious outcomes in emergency department acute heart failure patients. It was created from 3 cohorts from American and Canadian population. Since the Egyptian population differ from the American and Canadian population regarding the age at presentation with cardiovascular disease, risk factors and etiology of the acute heart failure, we sought to detect the applicability of this score on our population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute heart failure
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Describe the management and outcomes of ED patients with acute heart failure
Time frame: 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 27206819Ponikowski 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.
- Results publication: PubMed 23570474Stiell 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.
- Results publication: PubMed 39129980Stiell 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Heart Failure (AHF)
RecruitingObservational study
Comprehensive Clinical Prediction Rule for Acute Heart Failure
Acute Heart Failure (AHF)
Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Not yet recruiting
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF)
Acute Heart Failure (AHF)
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basma Mahrous Mohamed, Master student (01019534749 ext. 01019534749, mahrousbasma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the predictive value of the heart risk 6 scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664073, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.