Atrial FibrillationNCT02298738
Effect of Vit D on New-onset AF in Hypertension
An observational study of Atrial Fibrillation and Hypertension, run by Ankara University.
Trial summary
Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at particular risk of development of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients with new-onset AF. New onset AF was defined as AF identified for the first time by an electrocardiogram or ambulatory holter monitoring. Hypertension was defined as blood pressure ≥ 140/90 mmHg or a history of antihypertensive drug use.
Who may be able to join
- Hypertensive patients with new-onset AF
Who cannot join
- Established coronary artery disease
- Heart failure
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Significant heart valve disease
- Hyperthyroidism
Show all 11Show fewer
- Renal failure
- Any malignancy
- Acute infection
- Recent thoracic or abdominal surgery
- Under therapy of Vit D3
About this study
Official title: Relation of Low Vitamin D Levels and New-onset AF Among Hypertensive Patients
Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system (RAS) which is activated in hypertension may be the underlying mechanism of AF among hypertensive patients.
Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension, cardiovascular disease and obesity. Increased RAS activity is one of the postulated mechanisms by which vitamin D deficiency may trigger the development of hypertension and various cardiovascular diseases. On the basis of these data we hypothesized that hypovitaminosis D might be associated with new-onset AF among patients with hypertension.
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Atrial fibrillation, hypertension, vitamin D
- Medical subject headings
- Atrial Fibrillation, Hypertension
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 |
|---|---|---|
| New onset Atrial fibrillation | New-onset AF was defined as patients with hypertension and atrial fibrillation which was identified for the first time by an electrocardiogram or ambulatory holter monitoring. | |
| control | Hypertensive patients without atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypovitaminosis D
Identifying whether hypovitaminosis D is a risk factor for development of new-onset AF among hypertensive patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Ulaş Özcan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298738
- Sponsor's protocol ID
- AnkaraU
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Low Vitamin D Levels and New-onset AF Among Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02298738
- Acronym / sponsor ID
- AnkaraU
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Atrial fibrillation, hypertension, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system (RAS) which is activated in hypertension may be the underlying mechanism of AF among hypertensive patients.
Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension, cardiovascular disease and obesity. Increased RAS activity is one of the postulated mechanisms by which vitamin D deficiency may trigger the development of hypertension and various cardiovascular diseases. On the basis of these data we hypothesized that hypovitaminosis D might be associated with new-onset AF among patients with hypertension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New onset Atrial fibrillation | – | –New-onset AF was defined as patients with hypertension and atrial fibrillation which was identified for the first time by an electrocardiogram or ambulatory holter monitoring. |
| control | – | –Hypertensive patients without atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients with new-onset AF. New onset AF was defined as AF identified for the first time by an electrocardiogram or ambulatory holter monitoring. Hypertension was defined as blood pressure ≥ 140/90 mmHg or a history of antihypertensive drug use.
Key inclusion criteria (1 listed)
- Hypertensive patients with new-onset AF
Key exclusion criteria (11 listed)
- Established coronary artery disease
- Heart failure
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Significant heart valve disease
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
hypovitaminosis D
Time frame: Baseline
Identifying whether hypovitaminosis D is a risk factor for development of new-onset AF among hypertensive patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Hypertension, run by Ankara University.
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 11 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: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypovitaminosis D (time frame: Baseline). 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 24 Nov 2014.