Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Subjects With Hypertension (DIMOSPAF)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT02563379
• Date of registration: 28/09/2015
• Prospective Registration: No
• Primary sponsor: Evangelismos Hospital
• Public title: Association of Dipping Pattern or Early Morning Surge of BP With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Subjects With Hypertension (DIMOSPAF) DIMOSPAF
• Scientific title: Association Between Circadian Blood Pressure Patterns With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Hypertensive Subjects
• Date of first enrolment: September 2015
• Target sample size: 200
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02563379
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Emmanuel A. Andreadis, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension - Atrial Fibrillation

Primary Outcome(s)

Association between nighttime BP patterns and/or early morning surge with the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects [Time Frame: 12 months]

Secondary Outcome(s)

Association between SBP and/or DBP levels with the development of paroxysmal AF in hypertensive patients [Time Frame: 12 months]

Association between the degree of TOD and the development of paroxysmal AF in hypertensive patients [Time Frame: 12 months]

Association between office heart rate or mean 24-hr heart rate with the development of asymptomatic paroxysmal AF episodes. [Time Frame: 12 months]

Association between PP and the development of asymptomatic paroxysmal AF episodes [Time Frame: 12 months]

Secondary ID(s)

MBPS-0915-EA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors