Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Heart Failure Clinical Trial

Official title:

Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01414309
• Other study ID #: EP 1137
• Status: Terminated
• Phase: N/A
• First received: August 9, 2011
• Last updated: January 5, 2015
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2015
• Source: Respicardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients.

Description:

This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)

• Age is greater than or equal to 18 years

• Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:

• AHI greater than or equal to 20

• greater than or equal to 50% of classified events of a central nature

• less than 20% of the total AHI comprised of obstructive apnea events

• Diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening PSG, or since the date of the earliest test used for baseline, whichever is longer. Optimal medications include: beta blockade, ACE-I or ARB and diuretics unless contraindicated or not considered medically necessary.

Exclusion Criteria:

• Current or intended use of any mask-based therapy for central sleep apnea

• Baseline oxygen saturation less than or equal to 90% on a stable FiO2

• Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)

• History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study

• Unstable angina

• History of primary pulmonary hypertension

• Currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study

• If subject has an implanted cardiac resynchronization device (CRT), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment

• Life expectancy of less than 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Heart Failure
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Germany	Charite, Campus Virchow-Klinikum	Berlin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Sleep Therapy & Research Center, Alamo	San Antonio	Texas
United States	Central MN Heart at St Cloud	St Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Respicardia, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index and its components	The primary objective of the study is to determine the natural progression of central sleep apnea, using the apnea-hypopnea index (AHI) and its components evaluated at 6 months.	6 months	No
Secondary	Clinical status associated with sleep disordered breathing	Epworth Sleepiness Scale; Subject Global Assessment; Quality of life as measured by Minnesota Living with Heart Failure Questionnaire; HF Clinical Composite; Six-minute hall walk; NYHA Functional Class; Echocardiographic measures of structure and function; Subject medications	6 months	No

External Links

•   Sponsor's website