Clinical trial NCT01997866: Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
Official title: Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Congestive Heart Failure
Heart Failure
Keywords: Obstructive Sleep Apnea
Sleep Apnea
Congestive Heart Failure
Heart Failure
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Hospital Admissions
timeFrame: Compare the number of Hospital Admissions during the 12-month period immediately prior to the index admission to the number of Hospital Admissions during the 12-month period immediately following the study intervention
measure: Number of Hospitalized Days
timeFrame: Compare the number of Hospitalized Days during the 12-month period immediately prior to the index admission to the number of Hospitalized Days during the 12-month period immediately following the study intervention
measure: Number of Emergency Department Visits
timeFrame: Compare the number of Emergency Department Visits during the 12-month period immediately prior to the index admission to the number of Emergency Department Visits during the 12-month period immediately following the study intervention
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline to 6 weeks
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline to 12 months
measure: Functional Outcome of Sleep Quality
timeFrame: Change from Baseline to 3 months
measure: Functional Outcome of Sleep Quality
timeFrame: Change from Baseline to 12 months
measure: Residual Apnea Hypopnea Index
timeFrame: at 6 weeks
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline to 3 months
measure: Functional Outcome of Sleep Quality
timeFrame: Change from Baseline to 6 weeks
measure: Residual Apnea Hypopnea Index
timeFrame: at 3 months
measure: Residual Apnea Hypopnea Index
timeFrame: at 12 months
measure: % of nights with greater than 4 hours use of Continuous Positive Airway Pressure
timeFrame: at 6 weeks
measure: % of nights with greater than 4 hours use of Continuous Positive Airway Pressure
timeFrame: at 3 months
measure: % of nights with greater than 4 hours use of Continuous Positive Airway Pressure
timeFrame: at 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Leverence, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Nila Radhakrishnan, M.D.
role: STUDY_CHAIR
References: