Blood PressureNCT04309175
Long-term Atrial Pacing and Central Blood Pressure
A study testing base rate programming of a permanent cardiac pacemaker in people with Blood Pressure, run by Tartu University Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- base rate programming of a permanent cardiac pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 52Show fewer
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension
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
- Being tested
- base rate programming of a permanent cardiac pacemaker
- Keywords
- central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction
- Medical subject headings
- Sick Sinus Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
base rate programming of a permanent cardiac pacemakerDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Slow-Fast | Experimental | Not described Receives: Device: base rate programming of a permanent cardiac pacemaker |
| Fast-Slow | Experimental | Not described Receives: Device: base rate programming of a permanent cardiac pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure amplification change
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Medical Centre
- Responsible party
- Principal investigator, Tuuli Teeäär, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309175
- Sponsor's protocol ID
- 299/T-22
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04309175
- Acronym / sponsor ID
- 299/T-22
- Conditions
- Blood Pressure
- Keywords
- central blood pressure, sick sinus syndrome, pacemaker, hypertension, sinus node dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- North Estonia Medical Centre
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow-Fast | Experimental | Device: base rate programming of a permanent cardiac pacemaker |
| Fast-Slow | Experimental | Device: base rate programming of a permanent cardiac pacemaker |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (52 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| base rate programming of a permanent cardiac pacemakerBase 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) | Device | Fast-Slow, Slow-Fast |
Primary outcome
systolic blood pressure amplification change
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing base rate programming of a permanent cardiac pacemaker in people with Blood Pressure, run by Tartu University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priit Kampus, Dr (+3725200193, priit.kampus@regionaalhaigla.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure amplification change (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.