Long-term Atrial Pacing and Central Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04309175
• Other study ID #: 299/T-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: April 2022

Study information

• Verified date: March 2020
• Source: Tartu University Hospital
• Contact: Priit Kampus, Dr
• Phone: +3725200193
• Email: priit.kampus[@]regionaalhaigla.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Sick Sinus Syndrome

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	North Estonia Medical Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure amplification change		two months