Back to resultsUtility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
New york Heart Association Class II-IV
New york Heart Association Class I
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- NYHA-Class II-IV
Exclusion Criteria:
- Liver or renal dysfunction. --DM
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
New york Heart Association Class II-IV
New york Heart Association Class I
Arm Description
New york Heart Association Class II-IV heart failure
New york Heart Association Class I with no heart failure
Outcomes
Primary Outcome Measures
Number of participants with elevated markers (IL17)
Number of participants with elevated markers (IL17)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03772275
Brief Title
Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Official Title
Clinical and Economical Study Evaluating the Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New york Heart Association Class II-IV
Arm Type
Active Comparator
Arm Description
New york Heart Association Class II-IV heart failure
Arm Title
New york Heart Association Class I
Arm Type
Active Comparator
Arm Description
New york Heart Association Class I with no heart failure
Intervention Type
Diagnostic Test
Intervention Name(s)
New york Heart Association Class II-IV
Other Intervention Name(s)
Severe heart failure
Intervention Description
New york Heart Association Class II-IV " study of markers"
Intervention Type
Diagnostic Test
Intervention Name(s)
New york Heart Association Class I
Other Intervention Name(s)
No heart failure
Intervention Description
New york Heart Association Class I
Primary Outcome Measure Information:
Title
Number of participants with elevated markers (IL17)
Description
Number of participants with elevated markers (IL17)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
NYHA-Class II-IV
Exclusion Criteria:
Liver or renal dysfunction. --DM
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, Ph D
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama M Ibrahim, Prof
Organizational Affiliation
Prof of Clinical Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medhat M Eshmawy, Prof
Organizational Affiliation
Cardiology Department- Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nermin W Ishaq, Msc
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
State/Province
Elgharbia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nermin W Ishak, Msc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure
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