Status:
UNKNOWN
Long-term Atrial Pacing and Central Blood Pressure
Lead Sponsor:
Tartu University Hospital
Collaborating Sponsors:
North Estonia Medical Centre
Conditions:
Blood Pressure
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04309175
Start Date
April 1 2020
End Date
April 1 2022
Last Update
March 16 2020
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