Aortic Blood PressurePhase 4NCT03245996
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
A Phase 4 study testing AAI 40 bpm, AAI 60 bpm and AAI 90 bpm in people with Aortic Blood Pressure, run by Tartu University Hospital.
Trial summary
This study is divided into two parts: The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker The second part evaluates the acute effects of atenolol, nebivolol and ivabradine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Blood Pressure
- What is being tested?
- AAI 40 bpm, AAI 60 bpm and AAI 90 bpm
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2016
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years;
- dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm
Who cannot join
- average seated office brachial systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg; atrial pacing <40%;
- ventricular pacing >25%;
- unpaced QRS >120 ms and/or QTc >500 ms on 12-lead ECG;
- atrioventricular blockage at AAI-mode 90 bpm; resting HR >60 bpm at AAI-mode 40 bpm; irregular heart rate;
- automatic mode switching >10%;
- implantable cardioverter defibrillator or cardiac resynchronisation therapy pacemaker; treatment with digoxin, class Ic or III antiarrhythmic drugs;
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- history of acute coronary syndrome;
- stable angina pectoris;
- heart failure with reduced left ventricular ejection fraction;
- history of cerebrovascular event;
- diabetes mellitus;
- chronic kidney disease with eGFR <30 ml/min/m2;
- peripheral artery disease;
- clinically relevant heart valve disease;
- active cancer;
- acute or chronic inflammatory disease;
- severe chronic respiratory or liver disease;
- pregnancy or breastfeeding
- contraindication or intolerance to atenolol, nebivolol, ivabradine or adjuvants
About this study
Official title: The Impact of Heart Rate on Central Hemodynamics in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
This study is divided into two parts:
- The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker
- The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels
Read the detailed description
Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied.
- To investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change.
- Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (AAI-mode 60, 40 and 90 bpm).
- Conditions
- Aortic Blood Pressure
- Being tested
- AAI 40 bpm, AAI 60 bpm, AAI 90 bpm, Atenolol Pill, Nebivolol Pill
- Keywords
- sick sinus syndrome, heart rate, aortic blood pressure, artificial pacemaker, beta-blockers, ivabradine
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAI 40 bpmDevice
Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study
AAI 60 bpmDevice
Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study
AAI 90 bpmDevice
Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study
Atenolol PillDrug
50 or 100 mg of atenolol is administered to subjects in the second part of the study
Nebivolol PillDrug
5 mg of nebivolol is administered to subjects in the second part of the study
Ivabradine PillDrug
5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Experimental | Subjects with a cardiac pacemaker Receives: Device: AAI 40 bpm; Device: AAI 60 bpm; Device: AAI 90 bpm; Drug: Atenolol Pill; Drug: Nebivolol Pill; Drug: Ivabradine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
First part of the study: central systolic blood pressure
Measured: 3 minutes after heart rate change
Second part of the study: systolic blood pressure amplification
difference between peripheral and central systolic blood pressure
Measured: 3 hours after drug administration and 3 minutes after heart rate change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startJun 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuuli Teeäär, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245996
- Sponsor's protocol ID
- 14058
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data shared after completion of study as supplement to journal article
Publications
Teeaar T, Serg M, Paapstel K, Vahi M, Kals J, Cockcroft JR, Zilmer M, Eha J, Kampus P. Atenolol's Inferior Ability to Reduce Central vs Peripheral Blood Pressure Can Be Explained by the Combination of Its Heart Rate-Dependent and Heart Rate-Independent Effects. Int J Hypertens. 2020 Apr 26;2020:4259187. doi: 10.1155/2020/4259187. eCollection 2020.
PubMed 32395337Teeaar T, Serg M, Paapstel K, Kals J, Kals M, Zilmer M, Eha J, Kampus P. Heart rate reduction decreases central blood pressure in sick sinus syndrome patients with a permanent cardiac pacemaker. J Hum Hypertens. 2018 May;32(5):377-384. doi: 10.1038/s41371-018-0051-4. Epub 2018 Mar 27.
PubMed 29581554
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Heart Rate on Central Hemodynamics in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
- ClinicalTrials.gov ID
- NCT03245996
- Acronym / sponsor ID
- 14058
- Conditions
- Aortic Blood Pressure
- Keywords
- sick sinus syndrome, heart rate, aortic blood pressure, artificial pacemaker, beta-blockers, ivabradine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Aug 2017 (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 study is divided into two parts:
- The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker
- The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels
Detailed description
Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied.
- To investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change.
- Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (AAI-mode 60, 40 and 90 bpm).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Device: AAI 40 bpm, Device: AAI 60 bpm, Device: AAI 90 bpm, Drug: Atenolol Pill, Drug: Nebivolol Pill, Drug: Ivabradine PillSubjects with a cardiac pacemaker |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-75 years;
- dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm
Key exclusion criteria (19 listed)
- average seated office brachial systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg; atrial pacing <40%;
- ventricular pacing >25%;
- unpaced QRS >120 ms and/or QTc >500 ms on 12-lead ECG;
- atrioventricular blockage at AAI-mode 90 bpm; resting HR >60 bpm at AAI-mode 40 bpm; irregular heart rate;
- automatic mode switching >10%;
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 |
|---|---|---|
| AAI 40 bpmCardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study | Device | Subjects |
| AAI 60 bpmCardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study | Device | Subjects |
| AAI 90 bpmCardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study | Device | Subjects |
| Atenolol Pill50 or 100 mg of atenolol is administered to subjects in the second part of the study | Drug | Subjects |
| Nebivolol Pill5 mg of nebivolol is administered to subjects in the second part of the study | Drug | Subjects |
| Ivabradine Pill5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study | Drug | Subjects |
Primary outcome
First part of the study: central systolic blood pressure
Time frame: 3 minutes after heart rate change
Second part of the study: systolic blood pressure amplification
Time frame: 3 hours after drug administration and 3 minutes after heart rate change
difference between peripheral and central systolic blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Derived from this study: PubMed 32395337Teeaar T, Serg M, Paapstel K, Vahi M, Kals J, Cockcroft JR, Zilmer M, Eha J, Kampus P. Atenolol's Inferior Ability to Reduce Central vs Peripheral Blood Pressure Can Be Explained by the Combination of Its Heart Rate-Dependent and Heart Rate-Independent Effects. Int J Hypertens. 2020 Apr 26;2020:4259187. doi: 10.1155/2020/4259187. eCollection 2020.
- Derived from this study: PubMed 29581554Teeaar T, Serg M, Paapstel K, Kals J, Kals M, Zilmer M, Eha J, Kampus P. Heart rate reduction decreases central blood pressure in sick sinus syndrome patients with a permanent cardiac pacemaker. J Hum Hypertens. 2018 May;32(5):377-384. doi: 10.1038/s41371-018-0051-4. Epub 2018 Mar 27.
- Individual participant dataSharing planned: Yes. all data shared after completion of study as supplement to journal article
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AAI 40 bpm, AAI 60 bpm and AAI 90 bpm in people with Aortic 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 2 inclusion and 19 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: finished, as of the sponsor's last update on 10 Jul 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First part of the study: central systolic blood pressure (time frame: 3 minutes after heart rate change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245996, which also lists 2 linked publications.
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 10 Jul 2018.