Atrioventricular DyssynchronyNCT03973944
ReachPR Trial Resynchronization Therapy in Heart Failure Patients With Prolonged PR Interval
A study testing Cardiac resynchronization therapy in people with Atrioventricular Dyssynchrony and Heart Failure, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Prolongation of the electrocardiographic PR interval (PR interval > 200ms; also known as first-degree atrioventricular block) is frequently encountered in clinical practice and is generally considered as a benign sign. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atrioventricular Dyssynchrony, Heart Failure
- What is being tested?
- Cardiac resynchronization therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jun 2018to 13 Dec 2020
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for an ICD device according to current guidelines (24);
- Stable prolonged PR interval >230ms;
- LVEF (< 35%);
- New York Heart Association (NYHA) functional class II, III or ambulant IV;
- Stable sinus rhythm (no documented AF-episodes during the last 4 weeks prior to inclusion);
- Optimal HF (oral) medication, and on a stable medication scheme at least 1 month prior to enrolment; (2)
- Age ≥ 18 years and < 80 years.
Who cannot join
- Already implanted with an CRT device;
- Resting Heart rate >90 bpm;
- Left bundle branch block (LBBB) QRS morphology;
- QRS duration >150ms
- Recent myocardial infarction (within 40 days prior to enrolment);
- Recent coronary artery bypass graft or valve surgery (within 90 days prior to enrolment);
Show all 13Show fewer
- Chronic renal failure requiring dialysis;
- Presence of frequent ventricular premature beats (VPB) (>5% on 24h rhythm monitoring or >2 VPB's on ECG at enrolment);
- Moderate to severe aortic valve stenosis (AVA<1,5) or a mechanical aortic valve;
- No femoral arterial access;
- Second or third degree AV block;
- Life expectancy < 1 year;
- Enrolment in one or more ongoing studies that could influence the results of this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Floor Salden, MD, +31-43-3884520, floor.salden@mumc.nl
Frits Prinzen, PhD
About this study
Official title: Restoration of Atrioventricular Coupling by Cardiac Resynchronization Therapy in Heart Failure Patients With Prolonged PR Interval
Rationale: Prolongation of the electrocardiographic PR interval (PR interval > 200ms; also known as first-degree atrioventricular block) is frequently encountered in clinical practice and is generally considered as a benign sign. However, there is increasing evidence that a prolonged PR interval results in poor hemodynamic performance with elevated left ventricular (LV) end-diastolic pressures evidenced by diastolic mitral regurgitation. Previous studies have also associated a prolonged PR interval with a substantially increased risk of future atrial fibrillation (AF) and pacemaker-implantation, and increased risk of heart failure (HF) hospitalization and death. These risks stress the importance of proper atrioventricular (AV) coupling. Shortening of the PR interval may be especially important in heart failure patients and can be obtained by atrioventricular pacing. A possible adverse effect of ventricular pacing is that it results in ventricular dyssynchrony which may lead to worsening cardiac function. This effect may be prevented by applying atrio-biventricular pacing. Data from several previous (sub)studies have suggested this.
Objective: The purpose of this study is to investigate the acute hemodynamic effects of restoration of atrioventricular coupling by atrio-biventricular pacing in patients with heart failure and prolonged PR interval.
Read more
Study design: This study will be a multi-center, exploratory, prospective interventional, nonrandomized acute hemodynamic study, using patients as their own controls.
Study population: The study will enroll 26 patients with symptomatic heart failure, reduced left ventricular ejection fraction (LVEF) (< 35%) and prolonged PR interval (>230ms), but without seriously prolonged QRS duration (<150ms) or left bundle branch block (LBBB) QRS pattern, who are candidates for an implantable cardioverter defibrillator (ICD) device according to current guidelines.
Main study parameters/endpoints: The main study parameter will be the acute hemodynamic change in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing. Secondary parameters will be the acute hemodynamic changes in left ventricular dP/dt|max and left ventricular stroke volume (SV) by invasive measurements and in left ventricular stroke volume, diastolic mitral regurgitation and left ventricular diastolic filling time by echocardiography during atrioventricular optimization by atrio-biventricular pacing.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients are candidates for an ICD device in whom cardiac resynchronization therapy (CRT) can be considered according to current guidelines. Patients in the present study will receive a CRT-defibrillator (CRT-D). The risk and/or complications of the CRT-D implantation are not additional for this study. After the implantation, acute invasive hemodynamic measurements will be performed with a pressure-volume catheter, which is inserted via the femoral artery and adds approximately 30 minutes to the standard procedure. An extra radiation dose of approximately 50mGy is needed to place the pressure volume catheter in the LV cavity. Local vascular complications of femoral artery puncture like bleeding or damage to the vessel wall may occur but are rare. The non-invasive echocardiographic protocol one to two weeks after implantation will add approximately 45 minutes to the routine outpatient clinic visit. The patients do not have to visit the clinic outside the routine outpatient clinic visits before and after a CRT-D implantation. The patients will have the potential direct benefit from the procedure, by finding the patient's specific optimal (atrioventricular) settings and thereby reducing above described risks of a prolonged PR interval. In case of a worse hemodynamic performance due to the procedure, the CRT-D will be programmed to back up pacing and there is no harm for the patient outside the above subscribed extra measurements.
- Conditions
- Atrioventricular Dyssynchrony, Heart Failure
- Being tested
- Cardiac resynchronization therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapyDevice
Atrio-biventricular pacing to shorten the prolonged PR interval
| Study group | Role | What they receive |
|---|---|---|
| Cardiac resynchronization therapy | Other | AV coupling by atrio-biventricular pacing Receives: Device: Cardiac resynchronization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular stroke work
The acute hemodynamic changes in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing.
Measured: Acute measurements (during the cardiac resynchronization therapy device-implantation; duration: approximately 1 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start18 Jun 2018
- Primary completion13 Dec 2019 (estimated)
- Study completion13 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular DyssynchronyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Vernooy, MD,PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973944
- Sponsor's protocol ID
- NL60764.068.17
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Atrioventricular Coupling by Cardiac Resynchronization Therapy in Heart Failure Patients With Prolonged PR Interval
- ClinicalTrials.gov ID
- NCT03973944
- Acronym / sponsor ID
- NL60764.068.17
- Conditions
- Atrioventricular Dyssynchrony, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 13 Dec 2019 (estimated)
- Study completion
- 13 Dec 2020 (estimated)
- First posted
- 4 Jun 2019 (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.
Rationale: Prolongation of the electrocardiographic PR interval (PR interval > 200ms; also known as first-degree atrioventricular block) is frequently encountered in clinical practice and is generally considered as a benign sign. However, there is increasing evidence that a prolonged PR interval results in poor hemodynamic performance with elevated left ventricular (LV) end-diastolic pressures evidenced by diastolic mitral regurgitation. Previous studies have also associated a prolonged PR interval with a substantially increased risk of future atrial fibrillation (AF) and pacemaker-implantation, and increased risk of heart failure (HF) hospitalization and death. These risks stress the importance of proper atrioventricular (AV) coupling. Shortening of the PR interval may be especially important in heart failure patients and can be obtained by atrioventricular pacing. A possible adverse effect of ventricular pacing is that it results in ventricular dyssynchrony which may lead to worsening cardiac function. This effect may be prevented by applying atrio-biventricular pacing. Data from several previous (sub)studies have suggested this.
Objective: The purpose of this study is to investigate the acute hemodynamic effects of restoration of atrioventricular coupling by atrio-biventricular pacing in patients with heart failure and prolonged PR interval.
Study design: This study will be a multi-center, exploratory, prospective interventional, nonrandomized acute hemodynamic study, using patients as their own controls.
Study population: The study will enroll 26 patients with symptomatic heart failure, reduced left ventricular ejection fraction (LVEF) (< 35%) and prolonged PR interval (>230ms), but without seriously prolonged QRS duration (<150ms) or left bundle branch block (LBBB) QRS pattern, who are candidates for an implantable cardioverter defibrillator (ICD) device according to current guidelines.
Main study parameters/endpoints: The main study parameter will be the acute hemodynamic change in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing. Secondary parameters will be the acute hemodynamic changes in left ventricular dP/dt|max and left ventricular stroke volume (SV) by invasive measurements and in left ventricular stroke volume, diastolic mitral regurgitation and left ventricular diastolic filling time by echocardiography during atrioventricular optimization by atrio-biventricular pacing.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients are candidates for an ICD device in whom cardiac resynchronization therapy (CRT) can be considered according to current guidelines. Patients in the present study will receive a CRT-defibrillator (CRT-D). The risk and/or complications of the CRT-D implantation are not additional for this study. After the implantation, acute invasive hemodynamic measurements will be performed with a pressure-volume catheter, which is inserted via the femoral artery and adds approximately 30 minutes to the standard procedure. An extra radiation dose of approximately 50mGy is needed to place the pressure volume catheter in the LV cavity. Local vascular complications of femoral artery puncture like bleeding or damage to the vessel wall may occur but are rare. The non-invasive echocardiographic protocol one to two weeks after implantation will add approximately 45 minutes to the routine outpatient clinic visit. The patients do not have to visit the clinic outside the routine outpatient clinic visits before and after a CRT-D implantation. The patients will have the potential direct benefit from the procedure, by finding the patient's specific optimal (atrioventricular) settings and thereby reducing above described risks of a prolonged PR interval. In case of a worse hemodynamic performance due to the procedure, the CRT-D will be programmed to back up pacing and there is no harm for the patient outside the above subscribed extra measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac resynchronization therapy | Other | Device: Cardiac resynchronization therapyAV coupling by atrio-biventricular pacing |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Indication for an ICD device according to current guidelines (24);
- Stable prolonged PR interval >230ms;
- LVEF (< 35%);
- New York Heart Association (NYHA) functional class II, III or ambulant IV;
- Stable sinus rhythm (no documented AF-episodes during the last 4 weeks prior to inclusion);
Key exclusion criteria (13 listed)
- Already implanted with an CRT device;
- Resting Heart rate >90 bpm;
- Left bundle branch block (LBBB) QRS morphology;
- QRS duration >150ms
- Recent myocardial infarction (within 40 days prior to enrolment);
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 |
|---|---|---|
| Cardiac resynchronization therapyAtrio-biventricular pacing to shorten the prolonged PR interval | Device | Cardiac resynchronization therapy |
Primary outcome
Left ventricular stroke work
Time frame: Acute measurements (during the cardiac resynchronization therapy device-implantation; duration: approximately 1 hours)
The acute hemodynamic changes in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Related trials for Atrioventricular Dyssynchrony
Recruiting
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
Bradyarrhythmia, Atrioventricular Block
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.
Kevin Vernooy, MD,PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy in people with Atrioventricular Dyssynchrony and Heart Failure, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 13 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Floor Salden, MD (031 43 38 84520, f.salden@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular stroke work (time frame: Acute measurements (during the cardiac resynchronization therapy device-implantation; duration: approximately 1 hours)). 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 14 Aug 2019.