Peripartum CardiomyopathyNCT04927715
Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.
An observational study of Peripartum Cardiomyopathy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peripartum Cardiomyopathy
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: females who have been diagnosed and treated clinically for peripartum cardiomyopathy in our center in sohag university hospital
Who may be able to join
- This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag uniersity hosoital
Sohag
Ali mo Altaher, lecturer, 01003376529 ext. +20, dr.ali.altaher30@gmail.com
About this study
Official title: FDNC5 Genetic Polymorphism in Patients With Peripartum Cardiomyopathy
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.
- Conditions
- Peripartum Cardiomyopathy
- Keywords
- Peripartum Cardiomyopathy, Irisin
- Medical subject headings
- Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diseased | Females with peripartum cardiomyopathy | |
| Control | Healthy females |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irisin level
detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)
Measured: 4 months
FNDC5 Genotyping
whether homogenetic or heterogenetic
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start20 Feb 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum CardiomyopathyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ahmed Altaher, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927715
- Sponsor's protocol ID
- Soh-Med-21-02-26
- Status last verified
- Jan 2022
- First submitted
- 9 Jun 2021
- Last updated
- 19 Jan 2022
- 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDNC5 Genetic Polymorphism in Patients With Peripartum Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04927715
- Acronym / sponsor ID
- Soh-Med-21-02-26
- Conditions
- Peripartum Cardiomyopathy
- Keywords
- Peripartum Cardiomyopathy, Irisin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 16 Jun 2021 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diseased | – | –Females with peripartum cardiomyopathy |
| Control | – | –Healthy females |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- females who have been diagnosed and treated clinically for peripartum cardiomyopathy in our center in sohag university hospital
Key inclusion criteria (1 listed)
- This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Irisin level
Time frame: 4 months
detect the serum level of irisin hormone by ELIZA in nanogram/decilitre(ng/dl)
FNDC5 Genotyping
Time frame: 4 months
whether homogenetic or heterogenetic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripartum Cardiomyopathy, run by Sohag University 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 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali mo Altaher, lecturer (01003376529 ext. +20, dr.ali.altaher30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irisin level (time frame: 4 months). The study lists 2 primary outcomes in all. 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 19 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.