Obstructive Sleep ApneaNCT03804827
Sleep Disordered Breathing in Acute Congestive Heart Failure
An observational study of Obstructive Sleep Apnea and Heart Failure; With Decompensation, run by University of California, San Diego at 2 sites in United States.
Trial summary
The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Heart Failure; With Decompensation
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2019to 3 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted to University of California San Diego Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital with acutely decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or hospitalist (general medical) service.
Who may be able to join
- Patients age 18-80 years admitted to University of California San Diego La Jolla campus (Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital) with acute decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or inpatient general medical services.
Who cannot join
- Known diagnosis of sleep disordered breathing and on treatment while hospitalized.
- Suspected acute coronary syndrome as determined by the primary clinical team.
- Intensive care unit level care.
- Requiring advanced heart failure therapy such as inotrope infusion, mechanical circulatory support etc.
- Intolerance of study procedures.
- Clinical attending physician refusal
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altman Clinical and Translational Research Institute
San Diego, California, 92093-0990
University of California San Diego
San Diego, California, 92121
About this study
Official title: Impact of Sleep Disordered Breathing on Cardiac Injury in Acutely Decompensated Congestive Heart Failure
The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. A secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.
Read the detailed description
Consecutive patients admitted to the hospital with acutely decompensated heart failure will be identified for potential enrollment in this study. Enrolled patients will first be asked to complete questionnaires to assess their symptoms and risk of having sleep apnea.
Relevant information will be obtained from the electronic medical record (age, gender, body mass index, co-morbidities, medications, prior echocardiography results). Subjects will then undergo a "type III" portable monitoring sleep study on the first or second night of their hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not otherwise obtained clinically, echocardiography will be obtained within 48 hours of admission. After a period of medical management for acutely decompensated heart failure, subjects will then have a second portable sleep apnea study (with associated pre and post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or 6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay etc. will be collected from the electronic medical record. Blood samples will be processed, stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.
- Keywords
- Sleep, OSA, CSA, CHF, Heart Failure, Troponin
- Medical subject headings
- Sleep Apnea, Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure With Sleep Disordered Breathing | AHI3% >/= 5 events per hour of sleep. | |
| Heart Failure without Sleep Disordered Breathing | AHI3% < 5 events per hour of sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight Troponin Change Admission
Overnight change in serum troponin concentration PRE vs POST sleep
Measured: 10 hours
Overnight Troponin Change Discharge
Overnight change in serum troponin concentration PRE vs POST sleep
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 Jan 2019
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804827
- Sponsor's protocol ID
- 181121
- Status last verified
- Aug 2021
- First submitted
- 11 Jan 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Disordered Breathing on Cardiac Injury in Acutely Decompensated Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT03804827
- Acronym / sponsor ID
- 181121
- Keywords
- Sleep, OSA, CSA, CHF, Heart Failure, Troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. A secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.
Detailed description
Consecutive patients admitted to the hospital with acutely decompensated heart failure will be identified for potential enrollment in this study. Enrolled patients will first be asked to complete questionnaires to assess their symptoms and risk of having sleep apnea.
Relevant information will be obtained from the electronic medical record (age, gender, body mass index, co-morbidities, medications, prior echocardiography results). Subjects will then undergo a "type III" portable monitoring sleep study on the first or second night of their hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not otherwise obtained clinically, echocardiography will be obtained within 48 hours of admission. After a period of medical management for acutely decompensated heart failure, subjects will then have a second portable sleep apnea study (with associated pre and post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or 6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay etc. will be collected from the electronic medical record. Blood samples will be processed, stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure With Sleep Disordered Breathing | – | –AHI3% >/= 5 events per hour of sleep. |
| Heart Failure without Sleep Disordered Breathing | – | –AHI3% < 5 events per hour of sleep. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to University of California San Diego Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital with acutely decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or hospitalist (general medical) service.
Key inclusion criteria (1 listed)
- Patients age 18-80 years admitted to University of California San Diego La Jolla campus (Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital) with acute decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or inpatient general medical services.
Key exclusion criteria (6 listed)
- Known diagnosis of sleep disordered breathing and on treatment while hospitalized.
- Suspected acute coronary syndrome as determined by the primary clinical team.
- Intensive care unit level care.
- Requiring advanced heart failure therapy such as inotrope infusion, mechanical circulatory support etc.
- Intolerance of study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overnight Troponin Change Admission
Time frame: 10 hours
Overnight change in serum troponin concentration PRE vs POST sleep
Overnight Troponin Change Discharge
Time frame: 10 hours
Overnight change in serum troponin concentration PRE vs POST sleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Heart Failure; With Decompensation, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overnight Troponin Change Admission (time frame: 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.