Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxys… (NCT02563379) | Clinical Trial Compass
UnknownNot Applicable
Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Subjects With Hypertension (DIMOSPAF)
Greece200 participantsStarted 2015-09
Plain-language summary
The goals of our study are to determine a).the association between abnormal circadian BP and the development of paroxysmal AF in hypertensive patients, b).at which level of TOD, paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with HTN.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with essential HTN (office BP\>140/90mmHg) or patients receiving at least one antihypertensive medication (ie. RAAA inhibitors or diuretic), aged 18-85 years of age.
* Patients with at least one of the following risk factors, organ damage or other evidence of cardiovascular disease:
* Previous stroke
* Transient ischemic attack (TIA)
* Systemic embolism
* Diabetes mellitus type 2
* Obesity
* Obstructive sleep apnea (OSA)
* Dyslipidemia
* History of coronary artery disease (CAD)
* Valvular heart disease (VHD)
* Echocardiographic findings attributed to HTN (ie. diastolic dysfunction, LVH)
* White coat hypertension (WCH), masked hypertension (MH)
* Positive family history for rhythm disturbances
Exclusion Criteria:
* Patients already diagnosed with paroxysmal or permanent AF
* Severe renal insufficiency (eGFR according to MDRD formula \<25ml/min/1.73m2)
* Patients unable to attend follow-up visits
* Clinical evidence of severe heart failure
* Suspected secondary HTN
* Mental disorders
* Patients with cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between nighttime BP patterns and/or early morning surge with the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects