Heart failure (HF)
Conditions
Interventions
One group:Echocardiography assesses the Changes in Cardiac Function of heart failure by Cardiac Contractility Modulation for 4 years
0:Patient fulfilled into the study criteria will be enrolled. Baseline testing included echocardiography with RT3DE and TDI, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), 6-minute hall w
0:Patients will be implanted with CCM. They will be followed up at pre-determined time-points where assessment will be repeated, i.e. 1week, 1 month and 3 months. After 3-month of CCM treatment, the d
0:Afterwards, CCM will be restarted and patient will continue with long-term follow up and assessment.
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1). Heart failure (HF) patients with left ventricular ejection fraction less than or equal to 35% by echocardiography and New York Heart Association Class III or IV 2). Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, ß-blockers, etc. 3). QRS duration 130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians 4). If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled
Exclusion criteria
Exclusion criteria: 1). Subjects with severe symptomatic HF who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be <11 ml/kg/min 2). Subjects who have a potentially correctible cause of HF, such as valvular heart disease or congenital heart disease. 3). Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation. 4). Subjects who have been hospitalized for HF which required the use of intravenous diuretics or inotropic support within two weeks of enrollment. 5). Subjects without an implantable cardioverter defibrillator (ICD) who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of CCM. 6). Subjects who have an ICD who have had appropriate ICD firing during the past one month. 7). Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular contractions per 24 hours on baseline Holter monitoring (which reduce significantly reducing the amount of CCM delivery). 8). Subjects who have chronic atrial fibrillation or chronic atrial flutter. 9). Subjects whose exercise tolerance is limited by a condition other than HF (e.g., angina, chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions). 10). Subjects who are unable to participate in a 6-minute hall walk or a cardiopulmonary stress test. 11). Subjects who are scheduled for a coronary revascularization (CABG or PCI) procedure, or who have undergone a CABG procedure within three months or a PCI procedure within one month of enrollment. 12). Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated. 13). Subjects who have had a myocardial infarction within three months of enrollment. 14). Subjects who have mechanical tricuspid or aortic valves. 15). Subjects who have a prior heart transplant. 16). Subjects who have a previously implanted ICD which employs unipolar or integrated bipolar sensing 17). Subjects who are participating in another experimental protocol. 18). Subjects who are unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The goal of the proposed research project is to examine the detailed mechanisms of how cardiac contractility modulation (CCM) improves cardiac function in a mechanical perspective. This can be achieved by performing serial follow up assessment based on sensitive echocardiographic tools, namely tissue Doppler imaging (TDI) and real-time 3-dimensional echocardiography (RT3DE) and 2D speckle tracking technology.; | — |
Countries
China
Contacts
Public ContactCheuk Man Yu
Outcome results
None listed