Obesity ParadoxNCT03904329
Obesity Paradox in Non Valvular Atrial Fibrillation Regarding Outcomes: Fact or Fiction
An observational study of Obesity Paradox, run by Assiut University at 1 site in Egypt.
Trial summary
Obesity paradox In patient with non valvular atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity Paradox
- What is being tested?
- Oral Anticoagulant
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with non valvular atrial fibrillation within one year from 1/6/2019 to 31/5/2020 among patients with non valvular in assuit university hospitals
Who may be able to join
- patients presented with non valvular AF
- patients on oral anticoagulant
Who cannot join
- valvular AF
- Mental illness
- History of cerebrovascular stroke
- history of bleeding tendency
- history of Chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity Paradox in Non Valvular Atrial Fibrillation
Obesity paradox In patient with non valvular atrial fibrillation
Read the detailed description
Study role of obesity in outcomes of anticoagulation in patients with non valvular atrial fibrillation
- Conditions
- Obesity Paradox
- Being tested
- Oral Anticoagulant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AnticoagulantDrug
Oral tablets of anti coagulations either warfare or NOACs
| Study group | Role | What they receive |
|---|---|---|
| Obese Patients with non valvular AF | Obese Patients with non valvular AF using oral anti coagulants Receives: Drug: Oral Anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between obesity and outcomes in non valvular atrial fibrillation
To study effect of obesity in outcomes of non valvular atrial fibrillation regarding the effect of obesity in the outcome of anticoagulants
Measured: Sixth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Oct 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity ParadoxStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christena amir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904329
- Sponsor's protocol ID
- Assuit35
- Status last verified
- Feb 2022
- First submitted
- 25 Mar 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Paradox in Non Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03904329
- Acronym / sponsor ID
- Assuit35
- Conditions
- Obesity Paradox
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 Apr 2019 (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.
Obesity paradox In patient with non valvular atrial fibrillation
Detailed description
Study role of obesity in outcomes of anticoagulation in patients with non valvular atrial fibrillation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Patients with non valvular AF | – | Drug: Oral AnticoagulantObese Patients with non valvular AF using oral anti coagulants |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with non valvular atrial fibrillation within one year from 1/6/2019 to 31/5/2020 among patients with non valvular in assuit university hospitals
Key inclusion criteria (2 listed)
- patients presented with non valvular AF
- patients on oral anticoagulant
Key exclusion criteria (5 listed)
- valvular AF
- Mental illness
- History of cerebrovascular stroke
- history of bleeding tendency
- history of Chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral AnticoagulantOral tablets of anti coagulations either warfare or NOACs | Drug | Obese Patients with non valvular AF |
Primary outcome
Correlation between obesity and outcomes in non valvular atrial fibrillation
Time frame: Sixth months
To study effect of obesity in outcomes of non valvular atrial fibrillation regarding the effect of obesity in the outcome of anticoagulants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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 Obesity Paradox, run by Assiut 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 2 inclusion and 5 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 4 Aug 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 Christen Henan, Ressident (01201558854, Christenamir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between obesity and outcomes in non valvular atrial fibrillation (time frame: Sixth months). 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 4 Aug 2022.