Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure



Status:Withdrawn
Conditions:Insomnia Sleep Studies, Cardiology, Pulmonary, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 110
Updated:5/18/2017
Start Date:January 2015
End Date:April 2017

Use our guide to learn which trials are right for you!

Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services
and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the
STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood
Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of
Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea.
They will be followed to determine if treatment of Sleep Apnea improves their quality of
life and decreases their utilization of the Hospital and Emergency Department (ED).

Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or
visiting our outpatient Congestive Heart Failure clinic will be screened using the STOP-BANG
Scoring Model. Patients with high risk of Obstructive Sleep Apnea will be referred to the
Sleep Center physicians for evaluation and treatment. Patients will be followed for one year
to determine if the treatment for Sleep Apnea improves their Quality of Life and decreases
Hospital and Emergency Department utilization.

Inclusion criteria:

- Patient has:

1. CHF (systolic, diastolic, any etiology), or

2. Normal Ejection Fraction (EF) and most recent:

1. Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) > 400,

2. Age 50 and older: NTPBNP > 750,

3. If no NTPBNP done: then Brain Natriuretic Peptide (BNP) > 200 (some newly
referred patients will only have this available at their first visit, or

3. Normal EF, no BNP done, and CHF documented in History or Problem List

- Admitted to the Hospital Medicine service, General Medicine Teaching service,
Medicine Cardiology Team (MCT) service, Heart Failure service, or Community Health
and Family Medicine (CHFM) service, OR Patient of the Congestive Heart Failure Clinic

- Patient has had at least 2 encounters (hospital inpatient admission, hospital
observation admission, or ED visit) with University of Florida (UF) Health during the
12-month period immediately prior to the current admission (not including the current
admission).

- English Speaking

- Males & Females

- Age 18 to 110

- Agreement to return to Gainesville for regular follow-up visits

Exclusion criteria:

- Decisionally impaired, cognitively impaired, or demented patient who has a surrogate,
proxy, or guardian

- Current Drug/Alcohol abuse as evidenced by a) positive urine toxicology screen for
cocaine or amphetamines during current admission, b) positive blood alcohol level
upon admission, or c) documentation by current providers of continued abuse of
alcohol or drugs

- Previous diagnosis of sleep apnea and on current treatment

- Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia
or ventricular fibrillation in the hospital

- Evidence of current ischemia evidenced by elevated Troponin unrelated to Chronic
Kidney Disease, or < 6 weeks since Myocardial Infarction (MI)

- Palliative care or Life expectancy < 6 months

- Isolated Cor Pulmonale - predominantly right ventricular dysfunction, Right
Ventricular Systolic Pressure (RVSP) >50 and/or on the following medications for
pulmonary hypertension: sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), IV or
sub-cutaneous (SC) treprostinil (Remodulin®; Tyvaso™), ambrisentan (Letairis®),
bosentan (Tracleer®), IV epoprostenol, inhaled iloprost (Ventavis®)

- On 5 liters or greater of O2

- Self-Pay Status

- Known Pregnancy

- Vulnerable Subjects such as prisoners, decisionally impaired/comatose individuals,
terminally ill patients, UF/Shands/Veterans Administration (VA) staff, UF students
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials