Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

Status:	Recruiting
Conditions:	Insomnia Sleep Studies, Cardiology, Pulmonary
Therapuetic Areas:	Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	12/17/2017
Start Date:	May 2010
End Date:	June 2020
Contact:	Maggie Szeto
Email:	Maggie.Szeto@uhn.ca
Phone:	416-597-3422

A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial

Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the
heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is
associated with increased risk of hospitalizations and death. It is not known however whether
treating SA reduces these risks. This study is looking at whether a respiratory device known
as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations
and death in subjects with HF and SA. Study subjects will randomly receive either their
regular medications OR their regular medications plus ASV. They will be followed for
approximately 5 years and information relevant to their health will be collected and
compared.

Inclusion Criteria:

- American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or
hypertensive causes, present for at least 3 months

- Left Ventricular Ejection Fraction ≤ 45 %

- Optimal medical therapy for heart failure

- No change in active cardiac medications for 2 weeks prior to randomization,
beta-blockers must be started 3 months prior to randomization

- Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an
Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness

- Written informed consent

Exclusion Criteria:

- Heart failure due to primary valvular heart disease

- Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve
disease

- Hypertrophic obstructive or restrictive or post partum cardiomyopathy

- Exercise capacity limited by class IV angina pectoris

- Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization

- Active myocarditis

- Planned AICD or CRT

- Presence of a left-ventricular assist device

- Transplanted heart or expected to receive a transplanted heart within the next 6
months

- Pregnancy

- Current use of ASV or CPAP or treated with any investigational therapy during the last
4 weeks (including approved therapies being used in unapproved indications)

- A clinical history that would interfere with the objectives of this study or that
would in the investigator's opinion preclude safe conclusion of the study

- Any other medical, social, or geographical factor, which would make it unlikely that
the patient will comply with the study procedures (e.g. alcohol abuse, lack of
permanent residence, severe depression, disorientation, distant location, or history
of non-compliance)

- Any contraindication to ASV therapy as detailed in the device provider manual

We found this trial at

sites

Glacier View Research Institute, Kalispell Regional Medical Center

350 Heritage Way
Kalispell, Montana 59901

from

Kalispell, MT