Long-term Atrial Pacing and Central Blood Pressure

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04309175

Enrollment

Registered

2020-03-16

Start date

2020-04-30

Completion date

2022-04-30

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction

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

Interventions

DEVICEbase rate programming of a permanent cardiac pacemaker

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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
systolic blood pressure amplification change	two months

Contacts

Primary ContactPriit Kampus, Dr

priit.kampus@regionaalhaigla.ee+3725200193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026