Long-term Atrial Pacing and Central Blood Pressure
Primary Purpose
Blood Pressure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
base rate programming of a permanent cardiac pacemaker
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Slow-Fast
Fast-Slow
Arm Description
Outcomes
Primary Outcome Measures
systolic blood pressure amplification change
Secondary Outcome Measures
Full Information
NCT ID
NCT04309175
First Posted
March 12, 2020
Last Updated
March 13, 2020
Sponsor
Tartu University Hospital
Collaborators
North Estonia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT04309175
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital
Collaborators
North Estonia Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure
Keywords
central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Slow-Fast
Arm Type
Experimental
Arm Title
Fast-Slow
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
base rate programming of a permanent cardiac pacemaker
Intervention Description
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)
Primary Outcome Measure Information:
Title
systolic blood pressure amplification change
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priit Kampus, Dr
Phone
+3725200193
Email
priit.kampus@regionaalhaigla.ee
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Long-term Atrial Pacing and Central Blood Pressure
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