Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

NCT01164592 | Completed Phase 4 DMC

• 1 other identifier: 01a
• Study Type: interventional
• Target: 312
• Locations: 8 countries
• Sites: 94

Brief Summary

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Conditions

Heart Failure; Sleep Disorder; Cheyne Stokes Respiration

Keywords

Heart failure (HF); Sleep disordered breathing (SDB); Cheyne Stokes Respiration (CSR); Adaptive Servoventilation (ASV)

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo).

  Baseline (Randomization), 6- and 12 month-Follow-up-visit

Secondary Outcomes (10)

• Changes in left and right ventricular function

  Baseline (Randomization), 6-and 12-month-Follow-up visit

• Changes in LV systolic and diastolic indexed volumes

  Baseline (Randomization), 6- and 12-month-Follow-up-visit

• Changes in right ventricular (RV) systolic and diastolic indexed volumes

  Baseline (Randomization), 6- and 12-month-Follow-up-visit

• Changes in LV and RV mass

  Baseline (Randomization), 6- and 12-month-Follow-up-visit

• Changes in LV sphericity index and LV end-systolic global wall stress

  Baseline (Randomization), 6- and 12-month-Follow-up-visit

Study Arms (2)

Therapy with adaptive servo ventilation

ACTIVE COMPARATOR

optimal medical therapy + adaptive servoventilation

Device: adaptive servoventilation (ASV)

Optimal medical therapy according to guidelines

NO INTERVENTION

optimal medical therapy

Interventions

adaptive servoventilation (ASV) DEVICE

Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours

Also known as: Adaptive Servo-Ventilation with AutoSet CS

Therapy with adaptive servo ventilation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Over 22 years of age
• Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
• Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
• Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of \>15/hr with at least 50% central events and a central AHI of at least 10/hr
• Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
• Optimised medical treatment according to the applicable guidelines
• Able to provide informed consent
• Predominant central sleep apnoea (apnoea hypopnoea index \> 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
• Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)\<50% predicted
• Current use of Positive Airway Pressure (PAP) therapy
• Life expectancy \< 1 year for diseases unrelated to chronic heart failure
• Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
• Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
• Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
• Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial

Sponsors & Collaborators

• ResMed: lead

Study Sites (94)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Rivercity Private Hospital

Auchenflower, Queensland, 4066, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Melbourne Sleep Disorders Centre

East Melbourne, Victoria, 3002, Australia

Location

St. Vincents and Mercy Private Hospital

Melbourne, Victoria, 3065, Australia

Location

Hollywood Private Hospital (CVS)

Nedlands, Western Australia, 6009, Australia

Location

St. Anne's University Hospital

Brno, 65691, Czechia

Location

Helsinki University Hospital

Helsinki, 00290, Finland

Location

Unesta Research Centre

Tampere, 33520, Finland

Location

Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

Tampere, 33521, Finland

Location

Clinique Mutualiste des Eaux Claires

Grenoble, 38000, France

Location

CHU Grenoble, Hopital Michallon

Grenoble, 38043, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

DRK Krankenhaus

Alzey, 55232, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Charité Campus Mitte CCM

Berlin, 10117, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

POLIKUM Friedenau

Berlin, 12157, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

Location

Praxis für Lunge Herz und Schlaf

Bielefeld, 33617, Germany

Location

Kardiologische Praxis Marschner

Bonn, 53225, Germany

Location

Helios Klinikum Borna

Borna, 04552, Germany

Location

Kardiologie Brühl

Brühl, 50321, Germany

Location

Gemeinschaftspraxis Kardiologie Dr. Becker

Castrop-Rauxel, 44575, Germany

Location

Kardiologische Praxis Dr. Isbruch

Castrop-Rauxel, 44577, Germany

Location

Malteser Krankenhaus St. Hildegardis

Cologne, 50931, Germany

Location

Klinikum der Universität zu Köln- Herzzentrum

Cologne, 50937, Germany

Location

Klinikum der Universität zu Köln-Schlaflabor

Cologne, 50937, Germany

Location

Praxis Dr. Anselm Bäumer

Cologne, 51065, Germany

Location

Gemeinschaftspraxis Dres. Gysan/Heinzler/May

Cologne, 51105, Germany

Location

Praxis Dr. Hecker

Dortmund, 44135, Germany

Location

Kardiologische Praxis Dr. Wetzel

Dortmund, 44141, Germany

Location

Praxis Dr. Lodde

Dortmund, 44147, Germany

Location

Facharztzentrum Dresden-Neustadt GbR

Dresden, 01099, Germany

Location

Gemeinschaftpraxis Dres. Schmidt/Gronke

Dresden, 01219, Germany

Location

Praxis Dr. Hohensee

Dresden, 01277, Germany

Location

Herzzentrum Universität Dresden

Dresden, 01307, Germany

Location

Khs Florence-Nightingale

Düsseldorf, 40489, Germany

Location

Kardiologie Oberkassel

Düsseldorf, 40545, Germany

Location

Gemeinschaftspraxis PD Dr. Lankisch

Düsseldorf, 40597, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Kardiologie Praxis Dr. Bonnekamp

Essen, 45136, Germany

Location

Praxis Dr. Tekiyeh

Essen, 45136, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Kath. Kliniken Essen/ Philippusstift

Essen, 45359, Germany

Location

Gemeinschaftspraxis Dres. Guckenbiehl

Flonheim, 55237, Germany

Location

CardioVaskuläres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Praxis Dr. Diedrichs

Frechen, 50226, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Kardiologische Praxis Gütersloh

Gütersloh, 33330, Germany

Location

Gemeinschaftspraxis Dres Leischik/Littwitz

Hagen, 58095, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22291, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

B&B GmbH

Herne, 44623, Germany

Location

Cardio-Praxis Herne Dr. Furche

Herne, 44623, Germany

Location

Gemeinschaftspraxis Dr. Bruch

Herne, 44629, Germany

Location

Kardiologische Praxis Dr. Schlichting

Herne, 44649, Germany

Location

Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

Herne, 44651, Germany

Location

St. Elisabeth-Hospital Herten gGmbH

Herten, 45699, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Cardiopraxis Ingelheim

Ingelheim, 55218, Germany

Location

Gemeinschaftspraxis Dres. Dobler/Turin

Karlstadt am Main, 97753, Germany

Location

Universität Leipzig -Herzzentrum

Leipzig, 04289, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

Lübeck, 23538, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

Lübeck, 23538, Germany

Location

Praxis für Kardiologie Dr. med. Menz

Menden, 58706, Germany

Location

Krankenhaus Bethanien

Moers, 47441, Germany

Location

Kardiologische Praxis Dr. Schön

Mühldorf, 84453, Germany

Location

Evangelisches Krankenhaus Mülheim

Mülheim, 45468, Germany

Location

Lungenärzte am Rotkreuzplatz

München, 80634, Germany

Location

Klinikum Augustinum München

München, 81375, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Städtisches Khs Lukas

Neuss, 41472, Germany

Location

Kardiologische Praxis Nienburg

Nienburg, 31582, Germany

Location

Praxis Dr. Fröhlich

Ratingen, 40885, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Khs St. Adolf Stift

Reinbek, 21465, Germany

Location

Praxis Dr. Hein

Reinbek, 21465, Germany

Location

Katharinen Hospital Unna

Unna, 59423, Germany

Location

Praxis Dr. Gerritsen

Waldkraiburg, 84478, Germany

Location

Kardiologisch angiologische Gemeinschaftspraxis

Wiesbaden, 65183, Germany

Location

Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

Wiesbaden, 65183, Germany

Location

Missionsärztliche Klinik Würzburg

Würzburg, 97074, Germany

Location

Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Brompton Hospital

London, London, UK-SW36NP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Sleep Wake Disorders; Cheyne-Stokes Respiration; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Apnea; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Martin Cowie, Prof

  Royal Brompton Hospital, London

  PRINCIPAL INVESTIGATOR

• Holger Woehrle, MD

  ResMed

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: August 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

NL (1); FI (3); GB (1); AU (6); DE (77); FR (3); CZ (1); CH (2)