NCT03883854

Brief Summary

Heart failure is a common problem with a prevalence of 1-2% in general population and a major cause of mortality,morbidity and impaired quality of life. Anemia is afrequent comorbidity in stable heart failure patients and it increases morbidity in terms of frequent hospital admissions,impaired exercise capacity,poor quality of life ,and increased mortality

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 19, 2019

Last Update Submit

March 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of iron deficiency in systolic heart failure patients

    systolic heart failure is defined as ejection fraction \<50% absolute iron deficiency is serum ferritin\<100ug/l.Functional iron deficiency is defined as normal serum ferritin(100-300)ug/l with low transferrin saturation\<20%

    1 year

Study Arms (1)

1 group

Complete iron profile * serum iron * serum ferritin * total iron binding capacity * transferrin saturation (TSAT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all participants will undergoe 1. full history(including dietary history) 2. clinical examination. 3. transthoracic echocardiography:for measurement of ejection fraction 4. complete blood count 5. complete iron profile: serum iron -serum ferritin-total iron binding capacity-transferrin saturation.

You may qualify if:

  • males or females patients above age of 18years of age and clinically diagnosed with systolic heart failure,ejection fraction\<50% by echocardiography admitted in Assiut University hospital

You may not qualify if:

  • Known to be non cardiac condition causing iron deficiency(haemorrhoids,malignancy).
  • other conditions causing fluid overload(eg.renal failure on dialysis ). .congenital heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cleland JG, Khand A, Clark A. The heart failure epidemic: exactly how big is it? Eur Heart J. 2001 Apr;22(8):623-6. doi: 10.1053/euhj.2000.2493. No abstract available.

Biospecimen

Retention: NONE RETAINED

Full history (including dietary history) 2)clinical examination. 3)Transthoracic echocardiography : * Transthoracic echocardiography for measurement of ejection fraction by simpson s method 4)Complete blood count. 5)Complete iron profile * serum iron * serum ferritin * total iron binding capacity * transferrin saturation (TSAT) Anemia is defined as hemoglobin (Hb)\<13g/dl for males and \<12 g/dl for females based on world health organization definition (17) Absolute iron deficiency is serum ferritin (100ug/L) Functional iron deficiency is defined as normal serum ferritin (100-300)with low TAST\<20%

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Amr Youssef, MD

CONTACT

Ayman Hassan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

March 25, 2019

Primary Completion

March 26, 2020

Study Completion

October 20, 2020

Last Updated

March 22, 2019

Record last verified: 2019-03