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

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

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: Device: base rate programming of a permanent cardiac pacemaker

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Priit Kampus, Dr; Phone Number: +3725200193; Email: priit.kampus@regionaalhaigla.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Slow-Fast	Device: base 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)
Experimental: Fast-Slow	Device: base 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
systolic blood pressure amplification change	two months

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Collaborators: North Estonia Medical Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; pacemaker; central blood pressure; sinus node dysfunction; sick sinus syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Sick Sinus Syndrome
• Other Study ID Numbers: 299/T-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No