Chronotropic Incompetence, Heart Failure, ICD
Conditions
Keywords
defibrillator, heart failure, ICD, CRT-D, cardiac resynchronization therapy, rate response, CLS, closed-loop stimulation, accelerometer, chronotropic incompetence
Brief summary
Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life. Patients are being asked to participate in this study if they have a history of heart failure and have or are scheduled to be implanted with a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting that works with the cardiovascular system to optimize their heart rate during physical activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer setting, which also is able to adjust the heart rate by movement sensors, when necessary. This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by BIOTRONIK, Inc. There will be approximately 15 participants in this trial.
Detailed description
This study is a prospective, randomized, single-blind crossover study intended to enroll patients who are implanted or are scheduled to be implanted with a Biotronik CLS and accelerometer capable CRT-D device. Patients will serve as their own control group with regard to modes of rate-adaptive pacing. Patients with a previously implanted Biotronik CRT-D device with CLS-capability will be recruited from health care institutions in San Diego and all dedicated functional testing will be performed at the University of California, San Diego (UCSD). The goal enrollment target for analysis will be 15 patients, with up to 20 patients enrolled to allow for withdrawals. The purpose of this study is to evaluate whether changes to an implanted ICD can improve the functional status of patients with suspected chronotropic incompetence (CI). CI is a condition in which the heart rate is unable to adequately respond to meet the patient's physical demands, such as walking, climbing stairs, or doing household chores. CI is common in patients with cardiovascular disease, particularly in patients with heart failure. Common clinical management of patients with suspected CI is to activate an accelerometer setting in the cardiac resynchronization therapy with defibrillator (CRT-D) device. An accelerometer will adjust the heart rate to fit the physiological circumstances and needs of the patient based on patient movement only. BIOTRONIK is a company that has developed a novel technology included in the settings for CRT-D devices that offers CLS as an alternative to a standard accelerometer. CLS utilizes sensed electrical properties of the heart in order to assess what may be the best heart rate for both physical and mental demands. This study is designed to compare whether patients will benefit from CLS when compared with standard accelerometer technology.
Interventions
DEVICECLS Mode on Biotronik CRT-D
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
DEVICEAccelerometer Mode on Biotronik CRT-D
Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
Sponsors
Biotronik, Inc.
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with a BIOTRONIK CRT-D device (capable of CLS and accelerometer rate responsive pacing) * Patients at least 18 years old * Patients who have plausible symptoms of CI based on previous monitoring and clinical symptoms
Exclusion criteria
* Pregnant patients * Patients who are unwilling/unable to provide informed consent * Patients who are unable to complete study related procedures * Current persistent atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk Distance (6MWD) Test | Measured on day 14 and day 21. | Cardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period. |
| RAND-36 Questionnaire | Performed on day 14 and day 21. | Quality of life of subjects was measured by the RAND-36 which is a generic 36-item questionnaire that measures eight health-related domains stratified by physical health (physical functioning, role limitations due to physical health, pain, and general health) and emotional health (vitality, role limitations due to emotional problems, social functioning, and mental health). Each scale is directly transformed into a 0-100 scale for a total score range of 0-800. Higher scores represent a more favorable health status. This test was performed twice, once at the end of each intervention period. |
| Cardiopulmonary Exercise Testing (CPET) | Performed on day 14 and day 21. | Cardiovascular health benefits were determined by measuring the peak heart rate (HR) during Cardiopulmonary exercise testing (CPET). The CPET is performed on a standard treadmill according to the Naughton protocol. During the test, patients inspired room air through a low-resistance mask, and expired oxygen and carbon dioxide partial pressures were measured with a gas analyzer. HR was recorded every 30 seconds during exercise. All patients were encouraged to exercise to maximal effort. This test was performed twice, once at the end of each intervention period. |
| Patient Preference | Performed on day 21. | At the end of the study, patients were asked about personal preference regarding CLS over DDDR. |
Countries
United States
Participant flow
Recruitment details
Patients with HFrEF and CI implanted with a CRT-D capable of CLS programming at UCSD were eligible for this study. 102 patients were screened.
Pre-assignment details
12 patients signed consent form. 3 participants dropped out of study prior to randomization. 9 participants were randomized and completed study.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants were randomized to receive all interventions, therefore baseline characteristics will be reported together. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 69 years |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Cardiopulmonary Exercise Testing (CPET)
Cardiovascular health benefits were determined by measuring the peak heart rate (HR) during Cardiopulmonary exercise testing (CPET). The CPET is performed on a standard treadmill according to the Naughton protocol. During the test, patients inspired room air through a low-resistance mask, and expired oxygen and carbon dioxide partial pressures were measured with a gas analyzer. HR was recorded every 30 seconds during exercise. All patients were encouraged to exercise to maximal effort. This test was performed twice, once at the end of each intervention period.
Time frame: Performed on day 14 and day 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS Mode on Biotronik CRT-D | Cardiopulmonary Exercise Testing (CPET) | 110.7 beats per minute | Standard Deviation 14.7 |
| Accelerometer Mode on Biotronik CRT-D | Cardiopulmonary Exercise Testing (CPET) | 109.7 beats per minute | Standard Deviation 14.1 |
Primary
Patient Preference
At the end of the study, patients were asked about personal preference regarding CLS over DDDR.
Time frame: Performed on day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CLS Mode on Biotronik CRT-D | Patient Preference | 5 Participants |
| Accelerometer Mode on Biotronik CRT-D | Patient Preference | 4 Participants |
Primary
RAND-36 Questionnaire
Quality of life of subjects was measured by the RAND-36 which is a generic 36-item questionnaire that measures eight health-related domains stratified by physical health (physical functioning, role limitations due to physical health, pain, and general health) and emotional health (vitality, role limitations due to emotional problems, social functioning, and mental health). Each scale is directly transformed into a 0-100 scale for a total score range of 0-800. Higher scores represent a more favorable health status. This test was performed twice, once at the end of each intervention period.
Time frame: Performed on day 14 and day 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS Mode on Biotronik CRT-D | RAND-36 Questionnaire | 550.8 score on a scale | Standard Deviation 123.9 |
| Accelerometer Mode on Biotronik CRT-D | RAND-36 Questionnaire | 489.3 score on a scale | Standard Deviation 164.9 |
Primary
Six-minute Walk Distance (6MWD) Test
Cardiovascular health benefits were measured by the six-minute walk distance (6MWD) test. The 6MWD is a standardized field test to evaluate functional exercise performance. Subjects are instructed to walk as far as possible in 6 min on a flat surface. This test was performed twice, once at the end of each intervention period.
Time frame: Measured on day 14 and day 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS Mode on Biotronik CRT-D | Six-minute Walk Distance (6MWD) Test | 293.1 meters | Standard Deviation 90.2 |
| Accelerometer Mode on Biotronik CRT-D | Six-minute Walk Distance (6MWD) Test | 315.1 meters | Standard Deviation 95.5 |