Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure (IMPACT)

This study has been completed.
Sponsor:
Collaborators:
Boston Scientific Corporation
University of Pittsburgh
Information provided by:
VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT00521534
First received: August 24, 2007
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Sleep Related Breathing Disorder
Congestive Heart Failure
Device: CRT with atrial overdrive pacing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by VA Pittsburgh Healthcare System:

Enrollment: 19
Study Start Date: March 2006
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
CRT programmed to VDD pacing mode
B
CRT programmed to DDD with overdrive pacing based on first night average sinus rate.
Device: CRT with atrial overdrive pacing
Both groups receive CRT, one group receives atrial overdrive pacing

  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

Patients presenting to the electrophysiology service of the VAPHS for CRT implant are eligible.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00521534

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Boston Scientific Corporation
University of Pittsburgh
Investigators
Principal Investigator: Alaa Shalaby, MD VA Pittsburgh Healthcare System
  More Information

No publications provided by VA Pittsburgh Healthcare System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alaa Shalaby, MD, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT00521534     History of Changes
Other Study ID Numbers: 02345
Study First Received: August 24, 2007
Last Updated: September 17, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
Sleep related Breathing Disorder
Congestive Heart Failure
Atrial Overdrive Pacing
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014