Clinical trial NCT04309175: Long-term Atrial Pacing and Central Blood Pressure
Official title: Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Keywords: central blood pressure
sick sinus syndrome
pacemaker
hypertension
sinus node dysfunction
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: North Estonia Medical Centre
First posted: 2020-03-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: systolic blood pressure amplification change
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: