Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

NCT01997866 | Withdrawn

• 1 other identifier: 201300300
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Congestive Heart Failure; Heart Failure

Keywords

Obstructive Sleep Apnea; Sleep Apnea; Congestive Heart Failure; Heart Failure

Outcome Measures

Primary Outcomes (3)

• Number of Hospital Admissions

  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

• Number of Hospitalized Days

  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

• Number of Emergency Department Visits

  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 (12)

• Epworth Sleepiness Scale

  Change from Baseline to 6 weeks

• Epworth Sleepiness Scale

  Change from Baseline to 12 months

• Functional Outcome of Sleep Quality

  Change from Baseline to 3 months

• Functional Outcome of Sleep Quality

  Change from Baseline to 12 months

• Residual Apnea Hypopnea Index

  at 6 weeks

Study Arms (1)

Patients with Congestive Heart Failure

OTHER

STOP-BANG Scoring Model Polysomnogram Sleep Study

Other: STOP-BANG Scoring Model; Other: Polysomnogram Sleep Study

Interventions

STOP-BANG Scoring Model OTHER

Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure Clinic will be administered the STOP-BANG Scoring Model to determine whether they are considered high-risk or low-risk for Sleep Apnea.

Patients with Congestive Heart Failure

Polysomnogram Sleep Study OTHER

Patients determined by the STOP-BANG Scoring Model to be high-risk for Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. If medically indicated, a Polysomnogram Sleep Study will be performed.

Patients with Congestive Heart Failure

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Heart Failure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Leverence, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Nila Radhakrishnan, M.D.

  University of Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 28, 2013
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

US (1)