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

Primary Purpose

Heart Failure, Sleep Disorder, Cheyne Stokes Respiration

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

adaptive servoventilation (ASV)

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure (HF), Sleep disordered breathing (SDB), Cheyne Stokes Respiration (CSR), Adaptive Servoventilation (ASV)

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE-HF. The inclusion and exclusion criteria are listed here.

INCLUSION CRITERIA FOR SERVE-HF STUDY:

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

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

EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:

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
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

Sites / Locations

Westmead Hospital
Rivercity Private Hospital
Royal Adelaide Hospital
Melbourne Sleep Disorders Centre
St. Vincents and Mercy Private Hospital
Hollywood Private Hospital (CVS)
St. Anne's University Hospital
Helsinki University Hospital
Unesta Research Centre
Tampere University Hospital, Pirkanmaa sairaanhoitopiiri
Clinique Mutualiste des Eaux Claires
CHU Grenoble, Hopital Michallon
CHU de Poitiers
Universitätsklinikum Aachen
DRK Krankenhaus
Herzzentrum Bad Krozingen
Herz- und Diabeteszentrum NRW
Charité Campus Mitte CCM
Charité Campus Mitte
POLIKUM Friedenau
Unfallkrankenhaus Berlin
Jüdisches Krankenhaus Berlin
Praxis für Lunge Herz und Schlaf
Kardiologische Praxis Marschner
Helios Klinikum Borna
Kardiologie Brühl
Gemeinschaftspraxis Kardiologie Dr. Becker
Kardiologische Praxis Dr. Isbruch
Praxis Dr. Hecker
Kardiologische Praxis Dr. Wetzel
Praxis Dr. Lodde
Facharztzentrum Dresden-Neustadt GbR
Gemeinschaftpraxis Dres. Schmidt/Gronke
Praxis Dr. Hohensee
Herzzentrum Universität Dresden
Khs Florence-Nightingale
Kardiologie Oberkassel
Gemeinschaftspraxis PD Dr. Lankisch
Universitätsklinikum Essen
Kardiologie Praxis Dr. Bonnekamp
Praxis Dr. Tekiyeh
Ruhrlandklinik Essen
Kath. Kliniken Essen/ Philippusstift
Gemeinschaftspraxis Dres. Guckenbiehl
CardioVaskuläres Centrum Frankfurt
Praxis Dr. Diedrichs
Universitätsklinikum Freiburg
Kardiologische Praxis Gütersloh
Gemeinschaftspraxis Dres Leischik/Littwitz
Universitätsklinikum Hamburg-Eppendorf
Asklepios Klinik Barmbek
Universitätsklinikum Heidelberg
Thoraxklinik Heidelberg gGmbH
Lungenklinik Hemer
B&B GmbH
Cardio-Praxis Herne Dr. Furche
Gemeinschaftspraxis Dr. Bruch
Kardiologische Praxis Dr. Schlichting
Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet
St. Elisabeth-Hospital Herten gGmbH
Lungenfachklinik Immenhausen
Cardiopraxis Ingelheim
Gemeinschaftspraxis Dres. Dobler/Turin
Malteser Krankenhaus St. Hildegardis
Klinikum der Universität zu Köln- Herzzentrum
Klinikum der Universität zu Köln-Schlaflabor
Praxis Dr. Anselm Bäumer
Gemeinschaftspraxis Dres. Gysan/Heinzler/May
Universität Leipzig -Herzzentrum
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie
Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor
Praxis für Kardiologie Dr. med. Menz
Krankenhaus Bethanien
Kardiologische Praxis Dr. Schön
Evangelisches Krankenhaus Mülheim
Lungenärzte am Rotkreuzplatz
Klinikum Augustinum München
Universitätsklinikum Münster
Städtisches Khs Lukas
Kardiologische Praxis Nienburg
Praxis Dr. Fröhlich
Universitätsklinikum Regensburg
Khs St. Adolf Stift
Praxis Dr. Hein
Katharinen Hospital Unna
Praxis Dr. Gerritsen
Kardiologisch angiologische Gemeinschaftspraxis
Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck
Missionsärztliche Klinik Würzburg
Comprehensive Heart Failure Center, Universitätsklinikum Würzburg
University Medical Center Groningen
Cardiocentro Ticino
Ospedale Regionale di Lugano
Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Therapy with adaptive servo ventilation

Optimal medical therapy according to guidelines

Arm Description

optimal medical therapy + adaptive servoventilation

optimal medical therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in left and right ventricular function

Changes in LV systolic and diastolic indexed volumes

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

Changes in LV and RV mass

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

Changes in sleep duration and sleep stages as well as arousals

Changes in sleep-disordered breathing

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

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

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

Full Information

NCT ID

NCT01164592

First Posted

July 15, 2010

Last Updated

August 4, 2015

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT01164592

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Sleep Disorder, Cheyne Stokes Respiration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Therapy with adaptive servo ventilation

Arm Type

Active Comparator

Arm Description

optimal medical therapy + adaptive servoventilation

Arm Title

Optimal medical therapy according to guidelines

Arm Type

No Intervention

Arm Description

optimal medical therapy

Intervention Type

Device

Intervention Name(s)

adaptive servoventilation (ASV)

Other Intervention Name(s)

Adaptive Servo-Ventilation with AutoSet CS

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Changes in left and right ventricular function

Time Frame

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

Title

Changes in LV systolic and diastolic indexed volumes

Time Frame