Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Heart Failure Clinical Trial

Official title:

Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01997866
• Other study ID #: 201300300
• Status: Withdrawn
• Phase: N/A
• First received: November 1, 2013
• Last updated: May 16, 2017
• Start date: January 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Congestive Heart Failure
• Heart Failure
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• STOP-BANG Scoring Model
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.
• Polysomnogram Sleep Study
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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	Change from Baseline to 6 weeks
Secondary	Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	Change from Baseline to 12 months
Secondary	Functional Outcome of Sleep Quality	Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty	Change from Baseline to 3 months
Secondary	Functional Outcome of Sleep Quality	Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty	Change from Baseline to 12 months
Secondary	Residual Apnea Hypopnea Index	This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.	at 6 weeks
Secondary	Epworth Sleepiness Scale	Chance of Dozing Off - Scale: Never, Slight, Moderate, High	Change from Baseline to 3 months
Secondary	Functional Outcome of Sleep Quality	Level of Difficulty Performing Everyday Activities - Scale: Don't do this activity, No difficulty, A little difficulty, Moderate difficulty, Extreme difficulty	Change from Baseline to 6 weeks
Secondary	Residual Apnea Hypopnea Index	This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.	at 3 months
Secondary	Residual Apnea Hypopnea Index	This is a data download from the Continuous Positive Airway Pressure machine, indicating the effectiveness of the patient's breathing while wearing the machine.	at 12 months
Secondary	% of nights with greater than 4 hours use of Continuous Positive Airway Pressure	Compliance for a given night would be 4 hours use or more.	at 6 weeks
Secondary	% of nights with greater than 4 hours use of Continuous Positive Airway Pressure	Compliance for a given night would be 4 hours use or more.	at 3 months
Secondary	% of nights with greater than 4 hours use of Continuous Positive Airway Pressure	Compliance for a given night would be 4 hours use or more.	at 12 months