Long-term Atrial Pacing and Central Blood Pressure

NCT04309175 | Unknown

• 1 other identifier: 299/T-22
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Conditions

Blood Pressure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure amplification change

  two months

Study Arms (2)

Slow-Fast

EXPERIMENTAL

Device: base rate programming of a permanent cardiac pacemaker

Fast-Slow

EXPERIMENTAL

Device: base rate programming of a permanent cardiac pacemaker

Interventions

base rate programming of a permanent cardiac pacemaker DEVICE

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)

Fast-Slow; Slow-Fast

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tartu University Hospital: lead
• North Estonia Medical Centre: collaborator

MeSH Terms

Conditions

Sick Sinus Syndrome; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Central Study Contacts

Priit Kampus, Dr

CONTACT

+3725200193; priit.kampus@regionaalhaigla.ee

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cardiologist

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 16, 2020

Record last verified: 2020-03