Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
This study is ongoing, but not recruiting participants.
Sponsor:
Respicardia, Inc.
Information provided by (Responsible Party):
Respicardia, Inc.
ClinicalTrials.gov Identifier:
NCT01414309
First received: August 9, 2011
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
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.
| Condition |
|---|
|
Central Sleep Apnea Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea |
Resource links provided by NLM:
Further study details as provided by Respicardia, Inc.:
Primary Outcome Measures:
- Apnea-hypopnea index and its components [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Clinical status associated with sleep disordered breathing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Observational patients
Heart Failure patients with moderate to severe central sleep apnea
|
Detailed Description:
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414309
Locations
| United States, Minnesota | |
| Minneapolis Heart Institute | |
| Minneapolis, Minnesota, United States, 55407 | |
| Central MN Heart at St Cloud | |
| St Cloud, Minnesota, United States, 56303 | |
| United States, Texas | |
| Sleep Therapy & Research Center, Alamo | |
| San Antonio, Texas, United States, 78229 | |
| Germany | |
| Charite, Campus Virchow-Klinikum | |
| Berlin, Germany, D-13353 | |
Sponsors and Collaborators
Respicardia, Inc.
Investigators
| Study Director: | Robin Germany, M.D. | Respicardia, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Respicardia, Inc. |
| ClinicalTrials.gov Identifier: | NCT01414309 History of Changes |
| Other Study ID Numbers: | EP 1137 |
| Study First Received: | August 9, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Respicardia, Inc.:
|
Heart Failure Central Sleep Apnea Sleep Disordered Breathing Cardiac Dysfunction |
Additional relevant MeSH terms:
|
Apnea Heart Failure Sleep Apnea Syndromes Sleep Apnea, Central Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Heart Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013