Long-term Atrial Pacing and Central Blood Pressure

Study Overview
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Brief Summary
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This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are paced long-term at a slower vs faster heart rate

Official Title
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Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: base rate programming of a permanent cardiac pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years sick sinus syndrome permanent cardiac pacemaker with right atrial and right ventricular leads at least 3 months from implantation sinus rhythm percentage of atrial pacing at or above 80% since last interrogation percentage of ventricular pacing at or below 3% since last interrogation primary arterial hypertension antihypertensive drug treatment mean office brachial blood pressure below 140/90 mmHg mean home brachial blood pressure below 135/85 mmHg ability to understand and follow study protocol signed informed consent form Exclusion Criteria: inclusion criteria not fulfilled violation of study protocol by subject, investigator or third part high quality central hemodynamic measurements cannot be perfomed inter-arm difference in brachial systolic blood pressure 15 mmHg or above intrinsic QRS complex 130 ms or above more than three antihypertensive agents in use treatment with digoxin or agents from Vaughan-Williams classes Ic, III või IV frequent high atrial rate episodes coronary artery disease secondary hypertension resistant hypertension orthostatic hypotension heart failure with decreased or preserved left ventricular ejection fraction implantable cardioverter-defibrillator or cardiac resynchronization therapy significant valvular heart disease significant congenital heart disease body mass index ≥35 kg/m2 type I diabetes type II diabetes with cardiovascular complications or on insulin therapy other significant endocrine disease history of cerebrovascular attack carotid artery disease lower extremity arterial disease severe chronic obstructive pulmonary disease severe asthma severe sleep apnea interstitial pulmonary disease inhaled beta adrenergic agonist therapy active cancer treatment central nervous system degenerative disease systemic connective tissue disease abnormal TSH at present glomerular filtration rate ≤30 ml/min/m2 hemoglobin <100 g/L (female), <110 g/L (male) hepatic dysfunction alcohol abuse pregnancy or breastfeeding no health insurance provided by Estonian Health Insurance Fund withdrawal of informed consent loss of contact with a subject during study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow-Fast<br> | Device: base rate programming of a permanent cardiac pacemaker<br>* Base rate of a subject's pacemaker is set to a slower, and after wash-out, to a faster pacing rate (Slow-Fast Arm) or to a faster, and after wash-out, to a slower pacing rate (Fast-Slow Arm)<br>|
| Experimental: Fast-Slow<br> | Device: base rate programming of a permanent cardiac pacemaker<br>* Base rate of a subject's pacemaker is set to a slower, and after wash-out, to a faster pacing rate (Slow-Fast Arm) or to a faster, and after wash-out, to a slower pacing rate (Fast-Slow Arm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure amplification change |  | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, central blood pressure, sick sinus syndrome, hypertension, sinus node dysfunction