Heart Failure
Conditions
Keywords
Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction
Brief summary
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
Detailed description
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.
Interventions
DEVICEInsignia Plus / Ultra (Guidant/Boston Scientific)
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are in sinus rhythm * Patients who are on stable medical therapy * Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III * Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) \> 125 ng/l. * Left ventricular ejection fraction (LVEF) ≥ 50%
Exclusion criteria
* Patients with persistent atrial fibrillation or atrial flutter * Patients who are in complete heart block * Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures * Patients who have severe heart valve disease or valve replacement * Patients with a contraindication for a pacemaker system * Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing * Patients who have infiltrative or hypertrophic cardiomyopathy * Patients who have known severe pulmonary disease * Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) \> 160 mmHg or diastolic blood pressure (DBP) \> 95 mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. | 1 month post implant | Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | 6 months post implant | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 8 |
| Non-Randomized Patients Only implanted patients were randomized. All other patients fall into this group. | 19 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Enrollment to One Month | Ebrolled Patients but not Implanted | 0 | 0 | 6 |
| Enrollment to One Month | Physician Decision | 1 | 0 | 0 |
| Enrollment to One Month | Testing Failure | 0 | 0 | 13 |
Baseline characteristics
| Characteristic | Rate Adaptive Pacing (RAP) Off Then On | Non-Randomized Patients | Rate Adaptive Pacing (RAP) On Then Off | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 14 Participants | 4 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 1 Participants | 8 Participants |
| Age, Continuous | 65.8 years STANDARD_DEVIATION 12.1 | 68.1 years STANDARD_DEVIATION 11 | 68.4 years STANDARD_DEVIATION 7.1 | 67.6 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 8 participants | 19 participants | 5 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 3 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 2 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 13 | 0 / 19 |
| serious Total, serious adverse events | 7 / 13 | 0 / 19 |
Outcome results
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.
Time frame: 1 month post implant
Population: The following were required for a patient's dataset to be included in the analysis:~1. 2 CPX tests had to be performed at 1M (RAP On \& RAP Off),~2. Each 1M CPX test had to result in RER ≥ 1.05,~3. Trending data from the disk had to have been obtained during each 1M CPX test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rate Adaptive Pacing (RAP) On at One Month | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. | 12.47 ml/kg/min | Standard Deviation 2.02 |
| Rate Adaptive Pacing (RAP) Off at One Month | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. | 12.79 ml/kg/min | Standard Deviation 2.14 |
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.
Time frame: 6 months post implant
Population: The following were required for a patient's dataset to be included in the analysis:~1. 2 CPX tests had to be performed (1M with RAP Off, 6M with RAP On \[RAP was On from 1M to 6M\]),~2. Each CPX test had to result in RER ≥ 1.05,~3. Trending data from the disk had to have been obtained during each CPX test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rate Adaptive Pacing (RAP) On at One Month | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | 12.04 ml/kg/min | Standard Deviation 1.74 |
| Rate Adaptive Pacing (RAP) Off at One Month | Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month. | 13.09 ml/kg/min | Standard Deviation 2.35 |