Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

University of Florida

Status

Withdrawn

Conditions

Sleep Apnea

Heart Failure

Obstructive Sleep Apnea

Congestive Heart Failure

Treatments

Other: STOP-BANG Scoring Model

Other: Polysomnogram Sleep Study

Study type

Interventional

Funder types

Other

Identifiers

NCT01997866

201300300

Details and patient eligibility

About

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).

Full description

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.

Sex

All

Ages

18 to 110 years old

Volunteers

No Healthy Volunteers

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