Urocortin 2NCT05115552
Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide
An observational study of Urocortin 2, run by Assiut University.
Trial summary
1. Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings. 2. Assessment of the clinical utility of urocortin 2 in monitoring AHF patients. 3. Comparison between urocortin 2 and BNP as a biomarker in AHF patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urocortin 2
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Feb 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: both gender above 18 years old with acute decompensated heart failure without ACS or stroke in the past 3 months or severe valvular disease or severe CKD .
Who may be able to join
- Adult patients with acute decompensated heart failure.
Who cannot join
- Acute coronary syndrome or stroke in the past 3 months.
- Severe chronic kidney disease.
- Severe valve disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide as a Biomarker in Patients With Acute Heart Failure
- Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
- Assessment of the clinical utility of urocortin 2 in monitoring AHF patients.
- Comparison between urocortin 2 and BNP as a biomarker in AHF patients
Read the detailed description
Heart failure (HF) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .The pathophysiology of HF is a complex interplay of genetic and multiple molecular mechanisms (from inflammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2).
Monitoring of biomarkers in HF can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3).
Natriuretic peptide (NP) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). That facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining Renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). But the natriuretic peptide levels are significantly affected by weight, the NT- proBNP in obese subjects is much lower than normal weight subjects. (6). Other factors that affect BNP levels including gender, age and renal disease
- Conditions
- Urocortin 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the role of serum urocortin 2 levels
Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
Measured: baseline
Assessment of the clinical utility of urocortin 2 in monitoring AHF patients
Measured: baseline
Secondary outcomes (1)
Comparison between urocortin 2 and BNP
Comparison between urocortin 2 and BNP as a biomarker in AHF patients(which is more specific for AHF patients )
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urocortin 2Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christen Saad Welliam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115552
- Sponsor's protocol ID
- Urocortin 2 Biomarker
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide as a Biomarker in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05115552
- Acronym / sponsor ID
- Urocortin 2 Biomarker
- Conditions
- Urocortin 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Nov 2021 (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.
- Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
- Assessment of the clinical utility of urocortin 2 in monitoring AHF patients.
- Comparison between urocortin 2 and BNP as a biomarker in AHF patients
Detailed description
Heart failure (HF) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .The pathophysiology of HF is a complex interplay of genetic and multiple molecular mechanisms (from inflammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2).
Monitoring of biomarkers in HF can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3).
Natriuretic peptide (NP) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). That facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining Renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). But the natriuretic peptide levels are significantly affected by weight, the NT- proBNP in obese subjects is much lower than normal weight subjects. (6). Other factors that affect BNP levels including gender, age and renal disease
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- both gender above 18 years old with acute decompensated heart failure without ACS or stroke in the past 3 months or severe valvular disease or severe CKD .
Key inclusion criteria (1 listed)
- Adult patients with acute decompensated heart failure.
Key exclusion criteria (3 listed)
- Acute coronary syndrome or stroke in the past 3 months.
- Severe chronic kidney disease.
- Severe valve disease.
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
Evaluation of the role of serum urocortin 2 levels
Time frame: baseline
Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
Assessment of the clinical utility of urocortin 2 in monitoring AHF patients
Time frame: baseline
1 secondary outcome
Comparison between urocortin 2 and BNP
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urocortin 2, 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 1 inclusion and 3 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 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christen S. Welliam, resident (01283938578, christeensaad50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the role of serum urocortin 2 levels (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.