Mechanisms of Action of Adaptive Servoventilation

NCT00976417 | Completed

• 1 other identifier: 09/H0708/35
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB. The SERVE-HF study aims to look at the effect of a breathing support machine, or ventilator called Adaptive Servo-ventilation (ASV) on mortality in heart failure patients with central sleep apnoea. In this related sub-study the investigators want to look at how the ASV machine has its effect. The investigators will be carrying out tests in the laboratory to measure various aspects of the way that breathing is controlled to measure the effect that ASV has on patients. In addition measurements looking at activity levels will be made using an actiwatch device worn by patients for 14 consecutive days and nights. Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline and 3 months) to allow comparison of data between patients and controls.

Conditions

Heart Failure; Sleep Apnea Syndromes

Study Arms (2)

1. Patients in the control group

2. Patients in the intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients already recruited to the SERVE-HF study.

You may qualify if:

• Over 18 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 12 months
• Left ventricular ejection fraction (LVEF) \<40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
• Diagnosis of sleep disordered breathing SDB (apnoea-hypopnoea-index (AHI \>15/h) with ≥ 50% central events and a central AHI ≥ 10/h)
• Clinically stable with no change in medication and no hospitalisation in preceding month
• Optimised medical treatment according to the applicable guidelines
• Able to provide informed consent

You may not qualify if:

• Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1) \<50%
• 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

Sponsors & Collaborators

• ResMed: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Imperial College London: collaborator

Study Sites (1)

Royal Brompton Hospital and Imperial College

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood will be collected.

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mary Morrell, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-11

Locations

GB (1)