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This study will look at how pacing your heart may assist your daily activities and how you are feeling.
RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAP On then Off at 1 month visit | Experimental |
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| RAP Off then On at 1 month visit | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insignia Plus / Ultra (Guidant/Boston Scientific) | Device | Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. | Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time. | 1 month post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were "RAP On" for months 1 through 6. All participants were 'Rap On' for months 6 to 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Kass, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Associates of Northeast Arkansas | Jonesboro | Arkansas | 72401 | United States | ||
| Cardiovascular Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20123314 | Background | Kass DA, Kitzman DW, Alvarez GE. The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design. J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7. |
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Following enrollment, patients were had an exercise test to determine chronotropic incompetence (CI). If patients were not CI, they were deemed a Testing Failure and withdrawn from the study. CI patients that were then implanted with a pacemaker were randomized to the order of their Rate Adaptive Pacing therapy for the 2 one month exercise tests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rate Adaptive Pacing (RAP) On Then Off | Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month. |
| FG001 | Rate Adaptive Pacing (RAP) Off Then On | Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month. |
| FG002 | Non-Randomized Patients | Only implanted patients were randomized. All other patients fall into this group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment to One Month |
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| One Month Period A |
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| One Month Period B |
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| One Month to Six Months |
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| Six Months to Twelve Months |
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All participants were "RAP On" for months 1 through 6. All participants were 'Rap On' for months 6 to 12.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rate Adaptive Pacing (RAP) On Then Off | Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month. |
| BG001 | Rate Adaptive Pacing (RAP) Off Then On |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. | Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time. | The following were required for a patient's dataset to be included in the analysis:
| Posted | Mean | Standard Deviation | ml/kg/min | 1 month post implant |
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Entire study (twelve months)
Adverse events were collected for all enrolled patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Implanted Patients | All patients from the RAP On then Off group and from the RAP Off then On group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident (CVA) | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse reaction - Rash from ECG leads | Surgical and medical procedures |
Early study termination leading to small numbers of subjects analyzed and an inability to test study hypothesis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elke Sommerijns | Boston Scientific | +32 479 76 71 56 | elke.sommerijns@bsci.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months post implant |
| Louisville |
| Kentucky |
| 40205 |
| United States |
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21205 | United States |
| Mayo Clinic Foundation | Rochester | Minnesota | 55902 | United States |
| Tyler CV Consultants - Trinity Mother Frances | Tyler | Texas | 75701 | United States |
| Physician Decision |
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Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
| BG002 | Non-Randomized Patients | Only implanted patients were randomized. All other patients fall into this group. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Rate Adaptive Pacing (RAP) Off at One Month |
Rate Adaptive Pacing (RAP) Off for cardiopulmonary exercise test (CPX) at one month. |
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| Secondary | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were "RAP On" for months 1 through 6. All participants were 'Rap On' for months 6 to 12. | The following were required for a patient's dataset to be included in the analysis:
| Posted | Mean | Standard Deviation | ml/kg/min | 6 months post implant |
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| 7 |
| 13 |
| 10 |
| 13 |
| EG001 | Non-Randomized Patients | Only implanted patients were randomized. All other patients fall into this group. Adverse events were collected for all subjects, also for non-randomized patients. | 0 | 19 | 0 | 19 |
| Chronic cervical spondylosis | Musculoskeletal and connective tissue disorders |
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| Coronary Artery Disease | Cardiac disorders |
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| Gastrointestinal bleed | Gastrointestinal disorders |
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| Genitourinary | Renal and urinary disorders |
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| Heart Failure | Cardiac disorders |
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| Hematological - Anemia | Blood and lymphatic system disorders |
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| Hypertension | Cardiac disorders |
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| Integumentary | Skin and subcutaneous tissue disorders |
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| Knee replacement | Musculoskeletal and connective tissue disorders |
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| Lead Dislodgment, Right Atrial | Cardiac disorders |
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| Myocardial infarction | Cardiac disorders |
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| Nonsustained ventricular tachycardia (NSVT) | Cardiac disorders |
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| Pneumonia, lingular | Respiratory, thoracic and mediastinal disorders |
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| Rate response inappropriate - Pulse generator | Cardiac disorders |
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| Atrial flutter | Cardiac disorders |
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| Chest pain | Cardiac disorders |
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| Chest pain - due to acid reflux | Cardiac disorders |
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| Coughing, Shortness of Breath | Respiratory, thoracic and mediastinal disorders |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders |
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| Heart Failure | Cardiac disorders |
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| Integumentary - Herpes zoster | Skin and subcutaneous tissue disorders |
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| Integumentary - Skin reaction to adhesive | Surgical and medical procedures |
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| Myocardial infarction | Cardiac disorders |
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| Oversensing, Right Atrial | Cardiac disorders |
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| Rapid heart rate | Cardiac disorders |
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