Sleep Apnea and CRT Upgrading

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Wolfgang Dichtl, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01970423
First received: October 22, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cardiomyopathy
Device: CRT
Device: conventional right ventricular stimulation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Improvement of central sleep apnea [ Time Frame: January 2014 - January 2017 ] [ 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


Secondary Outcome Measures:
  • CRT response [ Time Frame: January 2014 - January 2017 ] [ 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


Estimated Enrollment: 80
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CRT
After randomization and polysomnography the CRT (INLIVIEN or INCEPTA) will get activated. After 3-5 months cross over to conventional right ventricular stimulation.
Device: CRT
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 Names:
  • INLIVEN (Boston Scientific)
  • INCEPTA (Boston Scientific)
Right Ventricular Stimulation
After randomization and polysomnography the conventional right ventricular stimulation will get activated. After 3-5 months cross over to CRT activation (INLIVIEN or INCEPTA).
Device: conventional right ventricular stimulation

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • NYAH IV
  • liver cirrhosis
  • renal insufficiency (GFR < 30ml/min/1,73m²)
  • expectancy of life < 1 year
  • premenopausal woman
  • drug or substance abuse
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970423

Contacts
Contact: Wolfgang Dicht, MD +43-512-504-81388 wolfgang.dichtl@uki.at

Locations
Austria
Medical University Innsbruck, Department for Internal Medicine III Not yet recruiting
Innsbruck, Austria, 6020
Contact: Wolgang Dichtl, PD Dr.    +43-512-504-81388    wolfgang.dichtl@uki.at   
Principal Investigator: Wolfgang Dichtl, MD         
Medical University Innsbruck, Internal Medicine III (Cardiology & Angiology) Recruiting
Innsbruck, Austria, 6020
Contact: Wolfgang Dichtl, MD, PhD    004351250481388    wolfgang.dichtl@uki.at   
Contact: Florian Hintringer, MD    004351250481312    florian.hintringer@uki.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Wolfgang Dichtl, MD Medical University of Innsbruck
  More Information

No publications provided

Responsible Party: Wolfgang Dichtl, Priv.-Doz. DDr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01970423     History of Changes
Other Study ID Numbers: UPGRADE
Study First Received: October 22, 2013
Last Updated: March 10, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University Innsbruck:
Patients with pacemaker or ICD therapy

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014