Heart FailureNCT06515366
MAP( Mean Arterial Pressure) and Mortality Relation in Patients With Heart Failure
An observational study of Heart Failure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients over the age of 18 with known heart failure, presenting to emergency department with acute exacerbation of heart failure symptoms will be grouped according to their measured mean arterial pressure (MAP)
Who may be able to join
- Age 18 and above Patients presenting with symptoms of heart failure
Who cannot join
- Age under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06170
gulsen akcay, ass. prof., +905052874949, gulakcay@yahoo.com.tr
elif hamzacebioglu kayisoglu, specalist, +905453300679, turkuaz-61@windowslive.com
About this study
Official title: Evaluation of the Relationship Between Mean Arterial Pressure (MAP) and Mortality in Patients With Heart Failure: A Perspective From Emergency Department Monitoring and Hospital Presentation
Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Our goal is to determine the impact of subgroup characteristics on mortality among patients presenting with heart failure in the emergency department, and to assess the predictive value and significance of MAP in predicting mortality.
Read the detailed description
After obtaining ethical approval, the study will commence within 2 weeks and continue for 1 year. Based on clinical statistics or general literature data, and considering sample size calculations, a total of 280 patients across 4 groups have been determined.
Inclusion Criteria:
Age 18 and above Patients presenting with symptoms of heart failure
Exclusion Criteria:
Age under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study
Groups based on initial mean arterial pressure (MAP) upon hospital admission will be established as follows: <65 mmHg, 66-80 mmHg, 81-100 mmHg, >100 mmHg. Data including results of emergency department tests and pertinent findings will be recorded for patients in these groups. The 30-day mortality rates of these patients will be statistically evaluated based on their MAP values and the procedures performed during emergency department monitoring.
- Conditions
- Heart Failure
- Keywords
- heart failure, mean arterial pressure, emergency department
- Medical subject headings
- Heart Failure, Emergencies
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 |
|---|---|---|
| MAP ≤ 65 mmHg | patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure ≤ 65 mmHg | |
| MAP 66-80 mmHg | patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 66-80 mmHg | |
| MAP 81-100 mmHg | patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 81-100 mmHg | |
| MAP >100 mmHg | patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between >100 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
patients having mortaility within 1 month of follow up
Measured: 1 month
Secondary outcomes (1)
re-hospitalization
patients being re-hospitalized within 1 month after discharge from hospital
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 280 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515366
- Sponsor's protocol ID
- MAP and Mortality
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma H, Li H, Sheng S, Quan L, Yang Z, Xu F, Zeng W. Mean arterial pressure and mortality in patients with heart failure: a retrospective analysis of Zigong heart failure database. Blood Press Monit. 2023 Dec 1;28(6):343-350. doi: 10.1097/MBP.0000000000000674. Epub 2023 Sep 14.
PubMed 37702595Burstein B, Tabi M, Barsness GW, Bell MR, Kashani K, Jentzer JC. Association between mean arterial pressure during the first 24 hours and hospital mortality in patients with cardiogenic shock. Crit Care. 2020 Aug 20;24(1):513. doi: 10.1186/s13054-020-03217-6.
PubMed 32819421Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R, Li P, Nie S, Li Y, Su L. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023 Aug;10(4):2362-2374. doi: 10.1002/ehf2.14401. Epub 2023 May 12.
PubMed 37177860
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Mean Arterial Pressure (MAP) and Mortality in Patients With Heart Failure: A Perspective From Emergency Department Monitoring and Hospital Presentation
- ClinicalTrials.gov ID
- NCT06515366
- Acronym / sponsor ID
- MAP and Mortality
- Conditions
- Heart Failure
- Keywords
- heart failure, mean arterial pressure, emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Jul 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.
Aim of this observational study is to evaluate the relationship between mean arterial pressure (MAP) and mortality in patients presenting to the emergency department with acute heart failure, focusing on emergency department monitoring and subgroup presentations. Our goal is to determine the impact of subgroup characteristics on mortality among patients presenting with heart failure in the emergency department, and to assess the predictive value and significance of MAP in predicting mortality.
Detailed description
After obtaining ethical approval, the study will commence within 2 weeks and continue for 1 year. Based on clinical statistics or general literature data, and considering sample size calculations, a total of 280 patients across 4 groups have been determined.
Inclusion Criteria:
Age 18 and above Patients presenting with symptoms of heart failure
Exclusion Criteria:
Age under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study
Groups based on initial mean arterial pressure (MAP) upon hospital admission will be established as follows: <65 mmHg, 66-80 mmHg, 81-100 mmHg, >100 mmHg. Data including results of emergency department tests and pertinent findings will be recorded for patients in these groups. The 30-day mortality rates of these patients will be statistically evaluated based on their MAP values and the procedures performed during emergency department monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAP ≤ 65 mmHg | – | –patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure ≤ 65 mmHg |
| MAP 66-80 mmHg | – | –patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 66-80 mmHg |
| MAP 81-100 mmHg | – | –patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between 81-100 mmHg |
| MAP >100 mmHg | – | –patient having heart failure symptoms with known heart failure and presenting to emergency department with a mean arterial pressure between >100 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over the age of 18 with known heart failure, presenting to emergency department with acute exacerbation of heart failure symptoms will be grouped according to their measured mean arterial pressure (MAP)
Key inclusion criteria (1 listed)
- Age 18 and above Patients presenting with symptoms of heart failure
Key exclusion criteria (1 listed)
- Age under 18 Patients presenting with ST-elevation myocardial infarction Patients with acute kidney failure Pregnant patients Patients with inaccessible data for the parameters under study
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
mortality
Time frame: 1 month
patients having mortaility within 1 month of follow up
1 secondary outcome
re-hospitalization
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 37702595Ma H, Li H, Sheng S, Quan L, Yang Z, Xu F, Zeng W. Mean arterial pressure and mortality in patients with heart failure: a retrospective analysis of Zigong heart failure database. Blood Press Monit. 2023 Dec 1;28(6):343-350. doi: 10.1097/MBP.0000000000000674. Epub 2023 Sep 14.
- Background: PubMed 32819421Burstein B, Tabi M, Barsness GW, Bell MR, Kashani K, Jentzer JC. Association between mean arterial pressure during the first 24 hours and hospital mortality in patients with cardiogenic shock. Crit Care. 2020 Aug 20;24(1):513. doi: 10.1186/s13054-020-03217-6.
- Background: PubMed 37177860Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R, Li P, Nie S, Li Y, Su L. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023 Aug;10(4):2362-2374. doi: 10.1002/ehf2.14401. Epub 2023 May 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
gulsen akcay, ass. prof. study director
ass. prof. of organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gulsen akcay, ass. prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (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 NCT06515366, 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 23 Jul 2024.