NCT04927715

Brief Summary

this is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism in female patients with peripartum cardiomyopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

June 9, 2021

Last Update Submit

January 17, 2022

Conditions

Peripartum Cardiomyopathy

Keywords

Peripartum Cardiomyopathy, Irisin

Outcome Measures

Primary Outcomes (2)

  • Irisin level

    detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)

    4 months

  • FNDC5 Genotyping

    whether homogenetic or heterogenetic

    4 months

Study Arms (2)

Diseased

Females with peripartum cardiomyopathy

Control

Healthy females

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe studied disease peripartum cardiomyopathy is female specific
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

females who have been diagnosed and treated clinically for peripartum cardiomyopathy in our center in sohag university hospital

You may qualify if:

  • This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy

You may not qualify if:

  • Age less than 18 or more than 45 year old
  • females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag uniersity hosoital

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Condition Hierarchy (Ancestors)

Pregnancy Complications, CardiovascularPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiomyopathiesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Ali mo Altaher, lecturer

CONTACT

01003376529dr.ali.altaher30@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

February 20, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

EG(1)