AzTrials
AzTrials

Heart FailurePhase 4MSNCT01164592

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

A Phase 4 study testing adaptive servoventilation (ASV) in people with Heart Failure and Sleep Disorder, run by ResMed at 94 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
adaptive servoventilation (ASV)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
94 sitesin 8 countries
Study dates
Aug 2012to Jun 2015
Phase
Phase 4
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Able to provide informed consent
  • ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY
  • 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

Who cannot join

  • Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
  • Oxygen saturation at rest during the day 90% at the time of inclusion
  • 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
Show all 14Show fewer
  • 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
  • Acute myocarditis/pericarditis within 6 months prior to randomisation
  • Untreated or therapy refractory Restless legs Syndrome (RLS)
  • Pregnancy
  • ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY
  • Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
  • Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation

Trial locations and contacts

94 sites in 8 countries.

94 sites in 8 countries

Germany77 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • DRK Krankenhaus

    Alzey, 55232

  • Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545

  • Charité Campus Mitte CCM

    Berlin, 10117

  • Charité Campus Mitte

    Berlin, 10117

  • POLIKUM Friedenau

    Berlin, 12157

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

  • Praxis für Lunge Herz und Schlaf

    Bielefeld, 33617

  • Kardiologische Praxis Marschner

    Bonn, 53225

  • Helios Klinikum Borna

    Borna, 04552

  • Kardiologie Brühl

    Brühl, 50321

  • Gemeinschaftspraxis Kardiologie Dr. Becker

    Castrop-Rauxel, 44575

  • Kardiologische Praxis Dr. Isbruch

    Castrop-Rauxel, 44577

  • Malteser Krankenhaus St. Hildegardis

    Cologne, 50931

  • Klinikum der Universität zu Köln- Herzzentrum

    Cologne, 50937

  • Klinikum der Universität zu Köln-Schlaflabor

    Cologne, 50937

  • Praxis Dr. Anselm Bäumer

    Cologne, 51065

  • Gemeinschaftspraxis Dres. Gysan/Heinzler/May

    Cologne, 51105

  • Praxis Dr. Hecker

    Dortmund, 44135

  • Kardiologische Praxis Dr. Wetzel

    Dortmund, 44141

  • Praxis Dr. Lodde

    Dortmund, 44147

  • Facharztzentrum Dresden-Neustadt GbR

    Dresden, 01099

  • Gemeinschaftpraxis Dres. Schmidt/Gronke

    Dresden, 01219

  • Praxis Dr. Hohensee

    Dresden, 01277

  • Herzzentrum Universität Dresden

    Dresden, 01307

  • Khs Florence-Nightingale

    Düsseldorf, 40489

  • Kardiologie Oberkassel

    Düsseldorf, 40545

  • Gemeinschaftspraxis PD Dr. Lankisch

    Düsseldorf, 40597

  • Universitätsklinikum Essen

    Essen, 45122

  • Kardiologie Praxis Dr. Bonnekamp

    Essen, 45136

  • Praxis Dr. Tekiyeh

    Essen, 45136

  • Ruhrlandklinik Essen

    Essen, 45239

  • Kath. Kliniken Essen/ Philippusstift

    Essen, 45359

  • Gemeinschaftspraxis Dres. Guckenbiehl

    Flonheim, 55237

  • CardioVaskuläres Centrum Frankfurt

    Frankfurt, 60389

  • Praxis Dr. Diedrichs

    Frechen, 50226

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Kardiologische Praxis Gütersloh

    Gütersloh, 33330

  • Gemeinschaftspraxis Dres Leischik/Littwitz

    Hagen, 58095

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • B&B GmbH

    Herne, 44623

  • Cardio-Praxis Herne Dr. Furche

    Herne, 44623

  • Gemeinschaftspraxis Dr. Bruch

    Herne, 44629

  • Kardiologische Praxis Dr. Schlichting

    Herne, 44649

  • Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

    Herne, 44651

  • St. Elisabeth-Hospital Herten gGmbH

    Herten, 45699

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Cardiopraxis Ingelheim

    Ingelheim, 55218

  • Gemeinschaftspraxis Dres. Dobler/Turin

    Karlstadt am Main, 97753

  • Universität Leipzig -Herzzentrum

    Leipzig, 04289

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

    Lübeck, 23538

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

    Lübeck, 23538

  • Praxis für Kardiologie Dr. med. Menz

    Menden, 58706

  • Krankenhaus Bethanien

    Moers, 47441

  • Kardiologische Praxis Dr. Schön

    Mühldorf, 84453

  • Evangelisches Krankenhaus Mülheim

    Mülheim, 45468

  • Lungenärzte am Rotkreuzplatz

    München, 80634

  • Klinikum Augustinum München

    München, 81375

  • Universitätsklinikum Münster

    Münster, 48149

  • Städtisches Khs Lukas

    Neuss, 41472

  • Kardiologische Praxis Nienburg

    Nienburg, 31582

  • Praxis Dr. Fröhlich

    Ratingen, 40885

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Khs St. Adolf Stift

    Reinbek, 21465

  • Praxis Dr. Hein

    Reinbek, 21465

  • Katharinen Hospital Unna

    Unna, 59423

  • Praxis Dr. Gerritsen

    Waldkraiburg, 84478

  • Kardiologisch angiologische Gemeinschaftspraxis

    Wiesbaden, 65183

  • Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

    Wiesbaden, 65183

  • Missionsärztliche Klinik Würzburg

    Würzburg, 97074

  • Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Rivercity Private Hospital

    Auchenflower, Queensland, 4066

  • Melbourne Sleep Disorders Centre

    East Melbourne, Victoria, 3002

  • St. Vincents and Mercy Private Hospital

    Melbourne, Victoria, 3065

  • Hollywood Private Hospital (CVS)

    Nedlands, Western Australia, 6009

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Finland3 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Unesta Research Centre

    Tampere, 33520

  • Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

    Tampere, 33521

Other trials in Finland

France3 sites

  • Clinique Mutualiste des Eaux Claires

    Grenoble, 38000

  • CHU Grenoble, Hopital Michallon

    Grenoble, 38043

  • CHU de Poitiers

    Poitiers, 86000

Other trials in France

Switzerland2 sites

  • Cardiocentro Ticino

    Lugano, 6900

  • Ospedale Regionale di Lugano

    Lugano, 6903

Other trials in Switzerland

Czechia1 site

  • St. Anne's University Hospital

    Brno, 65691

Other trials in Czechia

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

United Kingdom1 site

  • Brompton Hospital

    London, London, UK-SW36NP

Other trials in United Kingdom

About this study

Official title: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

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.

Read the detailed description

This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.

For the purpose of this substudy, patients will be followed up for a period of 12 months.

The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:

  • Echocardiogram (for both groups)
  • cMRI (for both groups)
  • PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
  • 4 questionnaires (for both groups)
  • Additional blood testing (for both groups)
Being tested
adaptive servoventilation (ASV)
Keywords
Heart failure (HF), Sleep disordered breathing (SDB), Cheyne Stokes Respiration (CSR), Adaptive Servoventilation (ASV)
Medical subject headings
Heart Failure, Sleep Wake Disorders, Cheyne-Stokes Respiration, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adaptive servoventilation (ASV)Device

    Also called Adaptive Servo-Ventilation with AutoSet CS

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

Study groups in NCT01164592
Study groupRoleWhat they receive
Therapy with adaptive servo ventilationActive comparatoroptimal medical therapy + adaptive servoventilation
Receives: Device: adaptive servoventilation (ASV)
Optimal medical therapy according to guidelinesNo interventionoptimal medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (10)

  1. Changes in left and right ventricular function

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

  2. Changes in LV systolic and diastolic indexed volumes

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

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

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

  4. Changes in LV and RV mass

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

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

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

  6. Changes in sleep duration and sleep stages as well as arousals

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

  7. Changes in sleep-disordered breathing

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

  8. Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

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

  9. Changes in mental status assessed by Mini-Mental State Examination (MMSE)

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

  10. Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startAug 2012
  3. Primary completionApr 2015
  4. Study completionJun 2015

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164592
Sponsor's protocol ID
01a
Acronym
MS
Status last verified
Aug 2015
First submitted
15 Jul 2010
Last updated
7 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adaptive servoventilation (ASV) in people with Heart Failure and Sleep Disorder, run by ResMed at 94 sites in 8 countries.

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 9 inclusion and 14 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, Australia, Finland, France, Switzerland and 3 more countries. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo). (time frame: Baseline (Randomization), 6- and 12 month-Follow-up-visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164592.

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 7 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in