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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

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

Studies a U.S. FDA-regulated Device Product

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

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

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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