Sleep Apnea and CRT Upgrading
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional

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.
    

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.
    

Intervention name(s): CRT; conventional right ventricular stimulation
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): INLIVEN / VISIONIST (Boston Scientific); INCEPTA / AUTOGEN (Boston Scientific)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patients with pacemaker or ICD therapy