NCT03772275

Brief Summary

Clinical and Economic study of some new biomarkers in chronic heart failure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
17mo left

Started Oct 2018

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2018Oct 2027

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

8 years

First QC Date

December 7, 2018

Last Update Submit

December 8, 2018

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Number of participants with elevated markers (IL17)

    Number of participants with elevated markers (IL17)

    6 months

Study Arms (2)

New york Heart Association Class II-IV

ACTIVE COMPARATOR

New york Heart Association Class II-IV heart failure

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

Diagnostic Test: New york Heart Association Class I

Interventions

New york Heart Association Class II-IVDIAGNOSTIC_TEST

New york Heart Association Class II-IV " study of markers"

Also known as: Severe heart failure
New york Heart Association Class II-IV
New york Heart Association Class IDIAGNOSTIC_TEST

New york Heart Association Class I

Also known as: No heart failure
New york Heart Association Class I

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA-Class II-IV

You may not qualify if:

  • Liver or renal dysfunction. --DM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Elgharbia, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Osama M Ibrahim, Prof

    Prof of Clinical Pharmacy

    PRINCIPAL INVESTIGATOR

  • Medhat M Eshmawy, Prof

    Cardiology Department- Tanta University

    STUDY DIRECTOR

  • Nermin W Ishaq, Msc

    Clinical pharmacy Department- Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Ph D

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 11, 2018

Study Start

October 1, 2018

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

EG(1)