Sleep Related Breathing DisorderIMPACTNCT00521534
Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure
An observational study of Sleep Related Breathing Disorder and Congestive Heart Failure, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
Background and Introduction: SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Related Breathing Disorder, Congestive Heart Failure
- What is being tested?
- CRT with atrial overdrive pacing
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the electrophysiology service of the VAPHS for CRT implant are eligible.
Who may be able to join
- Age > 18years
- Indication for CRT device implant:
- Congestive heart failure (NYHA Class III or IV)
- Ejection fraction less than 36%
- Evidence of intraventricular dyssynchrony (QRS duration >120ms or positive tissue doppler echocardiogram).
- Have a life expectancy of at least 6 months
- Are on optimal pharmaceutical therapy (OPT)
- Ability and willingness to sign informed consent
Who cannot join
- Unstable angina, Canadian Cardiac Society Class III or greater.
- Patients with unstable heart failure defined as need for intravenous inotropes or inability to achieve stable medical regimen for 48 hours.
- Deterioration in CHF at any time during the study requiring hospital admission and any of the following:
- A significant change in pharmaceutical regimen (see below: Pharmacologic Therapy)
- A change in pacing mode parameters (with the exception of if the mode is inadvertently programmed incorrectly at implant)
- A need for inotrope support
Show all 16Show fewer
- A downward change in functional class by one grade at discharge
- Women of childbearing age who are pregnant or who refuse pregnancy test and reliable contraception means for the duration of the study.
- Not having a successful percutaneous CRT device implant.
- Chronic atrial fibrillation.
- Patients currently known to have sleep apnea for which they are being treated with CPAP. (Patients prescribed to CPAP who have not been compliant for one month or greater are eligible for enrollment.)
- AHI >50 on any PSG or portable sleep study.
- Mean nocturnal heart rate > 80 bpm on baseline PSG will exclude from randomization.
- Patients receiving, narcotics or benzodiazepines unless on stable doses.
- Current alcohol or narcotic abuse as documented in the patient medical record.
- Inability or unwillingness to sign informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
About this study
Background and Introduction:
SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart failure. The disorder is prevalent among males, estimated to affect upto 24% of the general population. Its prevalence increases with age, and it is particularly prevalent among patients with congestive heart failure with the prevalence rising to 51% in that group. Interestingly, recent evidence points to a potential impact for treating sleep disordered breathing, on heart failure patients. At the same time, recent reports of a beneficial impact of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs further exploration. The interdependence of potential positive impact on each entity needs to be elucidated for further research and refinement of therapeutic tools. Furthermore, this study aims to explore potential neurohormonal influence on and affection by each of these disorders.
Read more
Specific Aims and Hypotheses:
Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after implementation of therapy.
Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT.
Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation to its effects on CHF and SDB.
Hypothesis #2: CRT neuro-hormonal modulation is a common path in its effects on SDB and CHF.
Specific Aim #3: To assess prevalence of sleep disordered breathing (SDB) in patients with advanced congestive heart failure (CHF).
Hypothesis #3: SDB is prevalent yet under recognized in this patient population.
Research Design:
This is an observational study with a built in double blinded prospective randomized interventional substudy of a potential confounder i.e. atrial pacing. All patients will receive CRT with defibrillator for clinical indications (CRT-D). Investigators other than the EP physicians as well as patients will be blinded to the pacing mode. After screening and a run in period of back up pacing a baseline polysomnogram (PSG) will be performed. Patients will be randomized between atrial overdrive or atrial tracking pacing modes for six months, all patients receiving CRT. Sleep studies will be performed at baseline and at three month intervals. Subjects: Patients referred for implantation of CRT -D will be recruited for this trial. Patients are included only if they are indicated for such a device on clinical grounds. Outcome Measures: 1.Sleep quality related Parameters:The following will be collected at times of each PSG: MAP-PSQI, PSG parameters of sleep quality and architecture, apnea hypopnea index, and oxygen saturation as well as biochemical markers of sleep efficiency. 2.Heart Failure Parameters: The following will be obtained at times of each PSG: Minnesota Living with Heart Failure Questionnaire, Clinical and echocardiographic measures of heart failure progression and biochemical markers of heart failure severity.
Power Analysis: An improvement in SDB in both initial randomization arms is assumed, however we further assume the atrial overdrive arm will offer improvement over the atrial tracking arm of equal magnitude. An arbitrary estimate would be twenty percent improvement in atrial overdrive arm. The corresponding estimate is 40% improvement due to CRT. To achieve 0.80 power thirty four data sets need to be collected.
- Being tested
- CRT with atrial overdrive pacing
- Keywords
- Sleep related Breathing Disorder, Congestive Heart Failure, Atrial Overdrive Pacing, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT with atrial overdrive pacingDevice
Both groups receive CRT, one group receives atrial overdrive pacing
| Study group | Role | What they receive |
|---|---|---|
| A | CRT programmed to VDD pacing mode | |
| B | CRT programmed to DDD with overdrive pacing based on first night average sinus rate. Receives: Device: CRT with atrial overdrive pacing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Related Breathing DisorderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Boston Scientific Corporation, University of Pittsburgh
- Investigators
- Alaa Shalaby, MD, Principal investigator, VA Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521534
- Sponsor's protocol ID
- 02345
- Acronym
- IMPACT
- Status last verified
- Sep 2012
- First submitted
- 24 Aug 2007
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Shalaby A, Atwood CW, Selzer F, Suffoletto M, Gorcsan Iii J, Strollo P. Cardiac resynchronization therapy and obstructive sleep-related breathing disorder in patients with congestive heart failure. Pacing Clin Electrophysiol. 2011 May;34(5):593-603. doi: 10.1111/j.1540-8159.2010.03015.x.
PubMed 21609340
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00521534
- Acronym / sponsor ID
- IMPACT / 02345
- Keywords
- Sleep related Breathing Disorder, Congestive Heart Failure, Atrial Overdrive Pacing, Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Collaborators
- Boston Scientific Corporation, University of Pittsburgh
- Study start
- Mar 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Aug 2007 (estimated)
- 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.
Background and Introduction:
SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart failure. The disorder is prevalent among males, estimated to affect upto 24% of the general population. Its prevalence increases with age, and it is particularly prevalent among patients with congestive heart failure with the prevalence rising to 51% in that group. Interestingly, recent evidence points to a potential impact for treating sleep disordered breathing, on heart failure patients. At the same time, recent reports of a beneficial impact of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs further exploration. The interdependence of potential positive impact on each entity needs to be elucidated for further research and refinement of therapeutic tools. Furthermore, this study aims to explore potential neurohormonal influence on and affection by each of these disorders.
Specific Aims and Hypotheses:
Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after implementation of therapy.
Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT.
Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation to its effects on CHF and SDB.
Hypothesis #2: CRT neuro-hormonal modulation is a common path in its effects on SDB and CHF.
Specific Aim #3: To assess prevalence of sleep disordered breathing (SDB) in patients with advanced congestive heart failure (CHF).
Hypothesis #3: SDB is prevalent yet under recognized in this patient population.
Research Design:
This is an observational study with a built in double blinded prospective randomized interventional substudy of a potential confounder i.e. atrial pacing. All patients will receive CRT with defibrillator for clinical indications (CRT-D). Investigators other than the EP physicians as well as patients will be blinded to the pacing mode. After screening and a run in period of back up pacing a baseline polysomnogram (PSG) will be performed. Patients will be randomized between atrial overdrive or atrial tracking pacing modes for six months, all patients receiving CRT. Sleep studies will be performed at baseline and at three month intervals. Subjects: Patients referred for implantation of CRT -D will be recruited for this trial. Patients are included only if they are indicated for such a device on clinical grounds. Outcome Measures: 1.Sleep quality related Parameters:The following will be collected at times of each PSG: MAP-PSQI, PSG parameters of sleep quality and architecture, apnea hypopnea index, and oxygen saturation as well as biochemical markers of sleep efficiency. 2.Heart Failure Parameters: The following will be obtained at times of each PSG: Minnesota Living with Heart Failure Questionnaire, Clinical and echocardiographic measures of heart failure progression and biochemical markers of heart failure severity.
Power Analysis: An improvement in SDB in both initial randomization arms is assumed, however we further assume the atrial overdrive arm will offer improvement over the atrial tracking arm of equal magnitude. An arbitrary estimate would be twenty percent improvement in atrial overdrive arm. The corresponding estimate is 40% improvement due to CRT. To achieve 0.80 power thirty four data sets need to be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –CRT programmed to VDD pacing mode |
| B | – | Device: CRT with atrial overdrive pacingCRT programmed to DDD with overdrive pacing based on first night average sinus rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the electrophysiology service of the VAPHS for CRT implant are eligible.
Key inclusion criteria (8 listed)
- Age > 18years
- Indication for CRT device implant:
- Ability and willingness to sign informed consent
Key exclusion criteria (16 listed)
- Unstable angina, Canadian Cardiac Society Class III or greater.
- Patients with unstable heart failure defined as need for intravenous inotropes or inability to achieve stable medical regimen for 48 hours.
- Deterioration in CHF at any time during the study requiring hospital admission and any of the following:
- Women of childbearing age who are pregnant or who refuse pregnancy test and reliable contraception means for the duration of the study.
- Not having a successful percutaneous CRT device implant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT with atrial overdrive pacingBoth groups receive CRT, one group receives atrial overdrive pacing | Device | B |
Primary outcome
Not reported in the source record.
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 18 Sep 2012.
- Derived from this study: PubMed 21609340Shalaby A, Atwood CW, Selzer F, Suffoletto M, Gorcsan Iii J, Strollo P. Cardiac resynchronization therapy and obstructive sleep-related breathing disorder in patients with congestive heart failure. Pacing Clin Electrophysiol. 2011 May;34(5):593-603. doi: 10.1111/j.1540-8159.2010.03015.x.
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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.
Alaa Shalaby, MD principal investigator
VA Pittsburgh Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Related Breathing Disorder and Congestive Heart Failure, run by VA Pittsburgh Healthcare System at 1 site 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 8 inclusion and 16 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521534, which also lists 1 linked publication.
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 18 Sep 2012.