CompletedPhase 4

The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker

27 participantsStarted 2015-06

Plain-language 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 on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18-75 years; * dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm Exclusion Criteria: * 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; * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First part of the study: central systolic blood pressure

Timeframe: 3 minutes after heart rate change

Second part of the study: systolic blood pressure amplification

Timeframe: 3 hours after drug administration and 3 minutes after heart rate change

Trial details

NCT IDNCT03245996

SponsorTartu University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Aortic Blood Pressure trials