Sleep Apnea and CRT Upgrading
Device: conventional right ventricular stimulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Central Sleep Apnea and New-onset Cardiac Resynchronization in Patients With Conventional Pacemaker or ICD Therapy: a Multicenter, Randomized Clinical Trial|
- Improvement of central sleep apnea [ Time Frame: January 2014 - December 2016 ] [ Designated as safety issue: No ]
improvement of moderate / severe central sleep apnea (AHI ≥ 15/h) due to new onset CRT as compared to ongoing conventional right ventricular pacing
- reduction of mean RDI (respiratory disturbance index) as assessed by AP Scan® in the first 90-150 days after initiation to CRT as compared to conventional RV pacing
- reduction of AHI (apnea-hypopnea index) as assessed by polysomnography within 90-150 days after initiation to CRT as compared to conventional RV pacing
- Validation of the AP scan by the gold standard polysomnography [ Time Frame: January 2014 - December 2016 ] [ Designated as safety issue: No ]
- CRT response [ Time Frame: January 2014 - December 2016 ] [ Designated as safety issue: No ]
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
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
After randomization and polysomnography the CRT will get activated. After 3-5 months cross over to conventional right ventricular stimulation.
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.
Right Ventricular Stimulation
After randomization and polysomnography the conventional right ventricular stimulation will get activated. After 3-5 months cross over to CRT activation.
|Device: conventional right ventricular stimulation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970423
|Contact: Wolfgang Dicht, MDfirstname.lastname@example.org|
|Medical University Innsbruck, Department for Internal Medicine III||Not yet recruiting|
|Innsbruck, Austria, 6020|
|Contact: Wolgang Dichtl, PD Dr. +43-512-504-81388 email@example.com|
|Principal Investigator: Wolfgang Dichtl, MD|
|Medical University Innsbruck, Internal Medicine III (Cardiology & Angiology)||Recruiting|
|Innsbruck, Austria, 6020|
|Contact: Wolfgang Dichtl, MD, PhD 004351250481388 firstname.lastname@example.org|
|Contact: Florian Hintringer, MD 004351250481312 email@example.com|
|Principal Investigator:||Wolfgang Dichtl, MD||Medical University of Innsbruck|