NCT02298738

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

November 20, 2014

Last Update Submit

November 21, 2014

Conditions

Keywords

Atrial fibrillation, hypertension, vitamin D

Outcome Measures

Primary Outcomes (1)

  • hypovitaminosis D

    Identifying whether hypovitaminosis D is a risk factor for development of new-onset AF among hypertensive patients

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Hypertensive patients with new-onset AF

You may not qualify if:

  • Established coronary artery disease
  • Heart failure
  • Chronic obstructive pulmonary disease
  • Diabetes mellitus
  • Significant heart valve disease
  • Hyperthyroidism
  • Renal failure
  • Any malignancy
  • Acute infection
  • Recent thoracic or abdominal surgery
  • Under therapy of Vit D3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ozgur Ulas Ozcan

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

January 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11