Heart Failure
Conditions
Keywords
Chronotropic Incompetence, Heart Failure
Brief summary
This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF.
Detailed description
The Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients (CI Algorithm Study) is an acute data collection study using market released actigraphy devices (wGT3X-BT) and holter devices (DR 180) to measure study subjects' daily activities and surface ECG data simultaneously. The data will be analyzed to develop an algorithm to diagnose CI in patients with HF.
Interventions
DIAGNOSTIC_TESTChronotropic Incompetence Diagnostic Algorithm
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Case group subjects will complete study required protocol testing while wearing an experimental device, the ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. Results will be compared to a Control Group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
for the case group: * Patient is greater than 18 years of age and less than 70 years of old. * Patient is willing and able to give informed consent. * Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance. * New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients. * Patients can perform moderate exercise. * Left ventricular ejection fraction less than 55% but greater than 35%. Inclusion criteria for the control group: * Subject is greater than 18 years of age and less than 70 years of old. * Subject is willing and able to give informed consent.
Exclusion criteria
for the case group: * Patient is unable or unwilling to sign the patient informed consent. * Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device. * Patient has at least one pacemaker, ICD or CRT indications. * Patients has persistent atrial fibrillation (AF). * Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM). * Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ECG ST-segment shift \> 2mm at the resting. * New York Heart Association Class IV. * Less than 45 days after myocardial infarction. * Less than 3 months after acute heart failure. * Patient has uncontrolled hypertension. * Patient is pregnant. * Patient has a medical condition that would limit study participation. * Patient is enrolled in a concurrent study that may affect the outcome of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronotropic Incompetence Index of Patients With Heart Failure Disease | Implant through 6 months | Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics. Chronotropic Index = \[achieved maximal HR-resting HR\]/\[age-predicted maximal HR-resting HR\]. Normal CI is \ 1 with low CI considered \< 0.8 Measurement described as: Chronotropic index=HRR/metabolic reserve. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Case Group At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen. | 40 |
| Control Group Each subject of the control group will do the same test and examination with the subjects in the case group. | 8 |
| Total | 48 |
Baseline characteristics
| Characteristic | Case Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 11.7 | 59.5 years STANDARD_DEVIATION 3.2 | 55.3 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 30 Participants | 5 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 8 |
| serious Total, serious adverse events | 0 / 40 | 0 / 8 |
Outcome results
Primary
Chronotropic Incompetence Index of Patients With Heart Failure Disease
Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics. Chronotropic Index = \[achieved maximal HR-resting HR\]/\[age-predicted maximal HR-resting HR\]. Normal CI is \ 1 with low CI considered \< 0.8 Measurement described as: Chronotropic index=HRR/metabolic reserve.
Time frame: Implant through 6 months
Population: Compare the case group for chronotropic incompetence using the interventional algorithm versus those in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Case Group | Chronotropic Incompetence Index of Patients With Heart Failure Disease | 0.61 Index | Standard Deviation 0.11 |
| Control Group | Chronotropic Incompetence Index of Patients With Heart Failure Disease | 0.72 Index | Standard Deviation 0.01 |