Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Withdrawn before enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea, Sleep Apnea, Congestive Heart Failure, Heart Failure

In brief

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).

Key facts

Study ID

NCT01997866

Run by

University of Florida

People needed

0

Starts

2015-01-01

Expected to finish

2017-04-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has:
• CHF (systolic, diastolic, any etiology), or
• Normal Ejection Fraction (EF) and most recent:
• Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) > 400,
• Age 50 and older: NTPBNP > 750,
• If no NTPBNP done: then Brain Natriuretic Peptide (BNP) > 200 (some newly referred patients will only have this available at their first visit, or
• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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