CardiomyopathyNCT01970423
Sleep Apnea and CRT Upgrading
A study testing CRT and conventional right ventricular stimulation in people with Cardiomyopathy, run by Medical University Innsbruck at 2 sites in Austria.
Trial summary
Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of heart failure. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- CRT and conventional right ventricular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesAustria
- Study dates
- Jan 2014to Aug 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left ventricular ejection fraction < 50%
- implanted conventional pacemaker or ICD with a right ventricular pacing rate > 40% or planned "ablate and pace" therapy
- age 40 - 85 years
Who cannot join
- NYAH IV
- liver cirrhosis
- renal insufficiency (GFR < 30ml/min/1,73m²)
- expectancy of life < 1 year
- premenopausal woman
- drug or substance abuse
Show all 12Show fewer
- hyperthyreosis
- custodianship
- CM allergy
- any condition that may compromise the compliance of the patient, or would preclude the patient from successful completion of the study
- plaster allergy
- enrollment in another clinical trial
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Innsbruck, Department for Internal Medicine III
Innsbruck, 6020
Medical University Innsbruck, Internal Medicine III (Cardiology & Angiology)
Innsbruck, 6020
About this study
Official title: Central Sleep Apnea and New-onset Cardiac Resynchronization in Patients With Conventional Pacemaker or ICD Therapy: a Multicenter, Randomized Clinical Trial
Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of heart failure.
Read the detailed description
Within the last decade cardiac resynchronization therapy (CRT) has been proven to be an effective therapy to reduce morbidity and mortality in chronic heart failure patients with wide QRS complex, in particular complete left bundle branch block. New indications have recently been established, including patients with mild symptoms and patients in need of conventional pacing such as high-grade atrioventricular block.
More than half - up to 80% - of patients with heart failure suffer from concomitant sleep apnea (SA), which further worsens symptoms and prognosis. Cardiac resynchronization therapy may ameliorate sleep apnea, but only the central form of sleep apnea (CSA). However, only very small uncontrolled studies with mainly less than 20 patients have been reported so far concerning the interactions between CRT and sleep apnea, and no data are available in patients with conventional right ventricular pacing undergoing upgrading to CRT.
Therefore, we want to perform a study called UPGRADE which is characterized
- being the first randomized study comparing the effects of new-onset cardiac resynchronization therapy on moderate and severe central sleep apnea, defined by an AHI ≥ 15/h as assessed by polysomnography in patients with conventional right ventricular pacing which is known to decrease cardiac function, induce heart failure and atrial fibrillation
- using a new technology called AP Scan® which enables continuous and reliable monitoring of sleep-disordered breathing (SDB); this technology is further validated with polysomnography, the gold standard in the diagnosis and follow-up in patients with sleep apnea
Unfortunately, one third of patients still do not benefit from CRT (so-called non-responders). On the other hand, up to 20% of patients greatly benefit and completely recover in terms of normalization of left ventricular ejection fraction and/or functional capacity (so-called super-responders). Research is urgently needed to decrease the number of non-responders and increase the number of super-responders.
Patient selection is still based on QRS duration and its morphology. Echocardiography and other imaging techniques for mechanical dyssynchrony assessment have failed to be a useful predictor for adequate patient selection. Therefore, we further want to test whether CRT itself does not only improve concomitant sleep apnea, but also if preexisting sleep apnea predicts the response to CRT in patients with previously conventional right-ventricular pacing undergoing an upgrade to CRT by additional implantation of a left ventricular lead.
- Conditions
- Cardiomyopathy
- Being tested
- CRT, conventional right ventricular stimulation
- Keywords
- Patients with pacemaker or ICD therapy
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTDevice
Also called INLIVEN / VISIONIST (Boston Scientific), INCEPTA / AUTOGEN (Boston Scientific)
The new device is the first CRT-P that relies on a physiological parameter, respiration, to allow the pacemaker to follow the patient's breath and help create an appropriate pacing rate.
conventional right ventricular stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| CRT | Other | After randomization and polysomnography the CRT will get activated. After 3-5 months cross over to conventional right ventricular stimulation. Receives: Device: CRT |
| Right Ventricular Stimulation | Other | After randomization and polysomnography the conventional right ventricular stimulation will get activated. After 3-5 months cross over to CRT activation. Receives: Device: conventional right ventricular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of central sleep apnea
improvement of moderate / severe central sleep apnea (AHI ≥ 15/h) due to new onset CRT as compared to ongoing conventional right ventricular pacing
Measured: January 2014 - June 2021
Validation of the AP scan by the gold standard polysomnography
Measured: January 2014 - June 2021
Secondary outcomes (1)
CRT response
secondary endpoints = CRT response according to pre-existing sleep apnea (RDI 0-14/h versus ≥ 15/h)
- improvement of left ventricular ejection fraction and reduction in left ventricular endsystolic volume as assessed by transthoracic echocardiography
- decrease in NTproBNP / BNP plasma concentration
Measured: January 2014 - June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Dichtl, MD PhD, Medical University Innsbruck
- Investigators
- Wolfgang Dichtl, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970423
- Sponsor's protocol ID
- UPGRADE
- Status last verified
- Sep 2020
- First submitted
- 22 Oct 2013
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sleep Apnea and New-onset Cardiac Resynchronization in Patients With Conventional Pacemaker or ICD Therapy: a Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01970423
- Acronym / sponsor ID
- UPGRADE
- Conditions
- Cardiomyopathy
- Keywords
- Patients with pacemaker or ICD therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 28 Oct 2013 (estimated)
- 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.
Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of heart failure.
Detailed description
Within the last decade cardiac resynchronization therapy (CRT) has been proven to be an effective therapy to reduce morbidity and mortality in chronic heart failure patients with wide QRS complex, in particular complete left bundle branch block. New indications have recently been established, including patients with mild symptoms and patients in need of conventional pacing such as high-grade atrioventricular block.
More than half - up to 80% - of patients with heart failure suffer from concomitant sleep apnea (SA), which further worsens symptoms and prognosis. Cardiac resynchronization therapy may ameliorate sleep apnea, but only the central form of sleep apnea (CSA). However, only very small uncontrolled studies with mainly less than 20 patients have been reported so far concerning the interactions between CRT and sleep apnea, and no data are available in patients with conventional right ventricular pacing undergoing upgrading to CRT.
Therefore, we want to perform a study called UPGRADE which is characterized
- being the first randomized study comparing the effects of new-onset cardiac resynchronization therapy on moderate and severe central sleep apnea, defined by an AHI ≥ 15/h as assessed by polysomnography in patients with conventional right ventricular pacing which is known to decrease cardiac function, induce heart failure and atrial fibrillation
- using a new technology called AP Scan® which enables continuous and reliable monitoring of sleep-disordered breathing (SDB); this technology is further validated with polysomnography, the gold standard in the diagnosis and follow-up in patients with sleep apnea
Unfortunately, one third of patients still do not benefit from CRT (so-called non-responders). On the other hand, up to 20% of patients greatly benefit and completely recover in terms of normalization of left ventricular ejection fraction and/or functional capacity (so-called super-responders). Research is urgently needed to decrease the number of non-responders and increase the number of super-responders.
Patient selection is still based on QRS duration and its morphology. Echocardiography and other imaging techniques for mechanical dyssynchrony assessment have failed to be a useful predictor for adequate patient selection. Therefore, we further want to test whether CRT itself does not only improve concomitant sleep apnea, but also if preexisting sleep apnea predicts the response to CRT in patients with previously conventional right-ventricular pacing undergoing an upgrade to CRT by additional implantation of a left ventricular lead.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT | Other | Device: CRTAfter randomization and polysomnography the CRT will get activated. After 3-5 months cross over to conventional right ventricular stimulation. |
| Right Ventricular Stimulation | Other | Device: conventional right ventricular stimulationAfter randomization and polysomnography the conventional right ventricular stimulation will get activated. After 3-5 months cross over to CRT activation. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- left ventricular ejection fraction < 50%
- implanted conventional pacemaker or ICD with a right ventricular pacing rate > 40% or planned "ablate and pace" therapy
- age 40 - 85 years
Key exclusion criteria (12 listed)
- NYAH IV
- liver cirrhosis
- renal insufficiency (GFR < 30ml/min/1,73m²)
- expectancy of life < 1 year
- premenopausal woman
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 |
|---|---|---|
| CRTAlso: INLIVEN / VISIONIST (Boston Scientific), INCEPTA / AUTOGEN (Boston Scientific)The new device is the first CRT-P that relies on a physiological parameter, respiration, to allow the pacemaker to follow the patient's breath and help create an appropriate pacing rate. | Device | CRT |
| conventional right ventricular stimulation | Device | Right Ventricular Stimulation |
Primary outcome
Improvement of central sleep apnea
Time frame: January 2014 - June 2021
improvement of moderate / severe central sleep apnea (AHI ≥ 15/h) due to new onset CRT as compared to ongoing conventional right ventricular pacing
Validation of the AP scan by the gold standard polysomnography
Time frame: January 2014 - June 2021
1 secondary outcome
CRT response
Time frame: January 2014 - June 2021
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 3 Sep 2020.
Related trials for Cardiomyopathy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Heart Failure, Left Ventricular Dysfunction
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.
Wolfgang Dichtl, MD principal investigator
Medical University Innsbruck
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT and conventional right ventricular stimulation in people with Cardiomyopathy, run by Medical University Innsbruck at 2 sites in Austria.
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 3 inclusion and 12 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 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
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?
Improvement of central sleep apnea (time frame: January 2014 - June 2021). 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?
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 3 Sep 2020.