An observational study in Atrial Fibrillation and Hypertension, sponsored by Hywel Dda Health Board. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Hywel Dda Health Board · Observational
Atrial fibrillation (AF) is the most common type of abnormal heart rhythm. This occurs as the chambers of the heart pump irregularly, often resulting in a fast heart rate and symptoms of irregular pounding and fluttering. There are many risk factors predisposing to AF, however, the cause cannot always be easily determined. Additionally, not all AF patients experience symptoms and consequently, this abnormal rhythm may go undetected and may be discovered accidentally. This is detrimental to patients, as untreated AF patients are at an increased risk of stroke.
Patients that are suspected of having AF are referred for an ultrasound scan of the heart (echocardiogram). It is expected to see structural changes to the heart's chambers. However, structural and electrical changes of the heart may be the cause of AF but may also be a result of AF, resulting in a chicken and egg situation. It may be possible that a different type of measurement can be used during an echocardiogram to detect subtle changes in heart muscle patterns. This measurement may then serve to be an early predictor of AF. This would be determined by comparing the patterns in patients with a normal, regular rhythm to those with AF.
Potential candidates are initially screened based on their echocardiogram referral. If deemed suitable for this study, the study process is explained to the patient and written informed consent is invited and received. The echocardiogram will be performed as normal with a focus on the area and volume measurements taken of one of the top chambers of the heart. An additional measurement will be taken to observe any subtle changes in the arrangement of heart cells within this same heart chamber. These measurements can be compared to each other to establish any relationship as well as compared to patients with and without AF.
Atrial fibrillation (AF) is the most prevalent type of arrhythmia within an adult population and is characterised by disorganised, chaotic, electrical activity and thus, ineffective atrial contraction causing irregular ventricular contraction. AF can be categorised into three different groups: paroxysmal, persistent and permanent. The prevalence of AF increases with age and is associated with a range of risk factors including: hypertension, obesity and alcohol consumption. There is a plethora of both cardiac and non-cardiac causes of AF and the cause is not always clear for each patient. Furthermore, causes of AF can also present as the by-product of AF, this increases the difficulty in determining the individual patient's cause of onset. A diagnosis of AF can be incidental as not all patients are symptomatic. If AF goes undetected, this puts the patient at an increased risk of blood clot formation and stroke.
Patients suspected of having AF are routinely referred for a transthoracic echocardiogram (TTE). It is common for AF patients to have a dilated left atrium (LA). This can be visually confirmed, and the LA area and volume can be measured during a TTE. LA strain measurements are not routinely measured during TTEs but may be able to detect subtle changes in longitudinal strain patterns of the myocardium. By comparing the strain patterns in patients with normal sinus rhythm (control) to those with AF, a scale can be created to suggest and predict whether a patient is likely to develop AF in the future based on these subtle changes before any changes in LA size occur. Furthermore, this can then be further developed to determine whether there are any significant differences in strain patterns between the three AF groups.
Objectives:
To determine whether there is a significant difference in atrial strain values between patients that are in normal sinus rhythm (NSR, control group) to patients that are known to have atrial fibrillation (disease group). A disease-control group of controlled hypertensive patients in NSR will also be utilised as hypertension is a known risk factor for atrial fibrillation.
Providing that there is a significant difference in the values between NSR and AF patients, a further comparison will be conducted on patients in different type of AF: paroxysmal AF, persistent AF and permanent AF to determine if there is a deterioration in atrial strain values within AF patients.
Left atrial area and volume size will also be measured in all patients and this can then be compared to atrial strain values.
6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.
This study's enrollment of 72 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Hywel Dda Health Board is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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To be included, patients had to be categorised into one of the following categories: normal sinus rhythm and normotensive, normal sinus rhythm and hypertensive, or known chronic atrial fibrillation. Additionally, all eligible patients had to conform to the aforementioned inclusion and exclusion criteria.
Criterion 1: subjects will be included in the study if they are within one of the following groups:
Exclusion Criteria:
All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants have blood pressure measurements within normal limits and are not prescribed anti-hypertensive medication.
Diagnostic Test: Transthoracic Echocardiogram
All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants are known to have raised blood pressure measurements previously and are receiving anti-hypertensive medication.
Diagnostic Test: Transthoracic Echocardiogram
All participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent).
Diagnostic Test: Transthoracic Echocardiogram
All participants have been referred for a transthoracic echocardiogram by a clinician.
Left atrial strain values
Taking measurements to assess left atrial strain from two different views (A4C \& A2C) as well as biplane measurements for reservoir, contractile and conduit LA strain.
Time frame: Baseline
LA volume size
Taking measurements to assess left atrial volume from two different views (A4C \& A2C) as well as biplane measurements.
Time frame: Baseline
LA area size
Taking measurements to assess left atrial area from A4C view.
Time frame: Baseline
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — All participant data has been pseudo-anonymised, this prevents any information from being able to be used to trace back to individual participants. Anonymised data may be able to be shared with other researchers rather than the mean data used in the data analyses.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Hywel Dda Health Board