Heart FailureNCT03772275
Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
A study testing New york Heart Association Class II-IV and New york Heart Association Class I in people with Heart Failure, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Clinical and Economic study of some new biomarkers in chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- New york Heart Association Class II-IV and New york Heart Association Class I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to Oct 2027
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NYHA-Class II-IV
Who cannot join
- Liver or renal dysfunction. --DM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta, Elgharbia, 35111
Nermin W Ishak, Msc
About this study
Official title: Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Clinical and Economic study of some new biomarkers in chronic heart failure.
Read the detailed description
The study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.
- Conditions
- Heart Failure
- Being tested
- New york Heart Association Class II-IV, New york Heart Association Class I
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New york Heart Association Class II-IVDiagnostic test
Also called Severe heart failure
New york Heart Association Class II-IV " study of markers"
New york Heart Association Class IDiagnostic test
Also called No heart failure
New york Heart Association Class I
| Study group | Role | What they receive |
|---|---|---|
| New york Heart Association Class II-IV | Active comparator | New york Heart Association Class II-IV heart failure Receives: Diagnostic Test: New york Heart Association Class II-IV |
| New york Heart Association Class I | Active comparator | New york Heart Association Class I with no heart failure Receives: Diagnostic Test: New york Heart Association Class I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with elevated markers (IL17)
Number of participants with elevated markers (IL17)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Oct 2018
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Osama M Ibrahim, Prof, Principal investigator, Prof of Clinical PharmacyMedhat M Eshmawy, Prof, Study director, Cardiology Department- Tanta UniversityNermin W Ishaq, Msc, Study chair, Clinical pharmacy Department- Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772275
- Sponsor's protocol ID
- Heart failure
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03772275
- Acronym / sponsor ID
- Heart failure
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Dec 2018 (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.
Clinical and Economic study of some new biomarkers in chronic heart failure.
Detailed description
The study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New york Heart Association Class II-IV | Active comparator | Diagnostic Test: New york Heart Association Class II-IVNew york Heart Association Class II-IV heart failure |
| New york Heart Association Class I | Active comparator | Diagnostic Test: New york Heart Association Class INew york Heart Association Class I with no heart failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NYHA-Class II-IV
Key exclusion criteria (1 listed)
- Liver or renal dysfunction. --DM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New york Heart Association Class II-IVAlso: Severe heart failureNew york Heart Association Class II-IV " study of markers" | Diagnostic test | New york Heart Association Class II-IV |
| New york Heart Association Class IAlso: No heart failureNew york Heart Association Class I | Diagnostic test | New york Heart Association Class I |
Primary outcome
Number of participants with elevated markers (IL17)
Time frame: 6 months
Number of participants with elevated markers (IL17)
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 11 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Osama M Ibrahim, Prof principal investigator
Prof of Clinical Pharmacy
Medhat M Eshmawy, Prof study director
Cardiology Department- Tanta University
Nermin W Ishaq, Msc study chair
Clinical pharmacy Department- Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New york Heart Association Class II-IV and New york Heart Association Class I in people with Heart Failure, run by Sherief Abd-Elsalam at 1 site in Egypt.
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: looking for participants now, as of the sponsor's last update on 11 Dec 2018. 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 Egypt. 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?
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 Sherief Abd-Elsalam, Ph D (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with elevated markers (IL17) (time frame: 6 months). 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 11 Dec 2018.