Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function
Study Details
Study Description
Brief Summary
This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Group The control group will be treated with practice guideline optimal medical therapy for HF. |
|
| Experimental: BiV-CRT The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT. |
Device: CRT
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT
|
| Experimental: CS-CRT The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT. |
Device: CRT
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT
|
Outcome Measures
Primary Outcome Measures
- NTproBNP measurement [12 Months]
The co-primary outcome measure is NTproBNP as measured at 12 months.
- 6-minute walk distance [12 Months]
The co-primary outcome measure is 6 minute hall walk distance as measured at 12 months.
- Quality of Life (QoL) score [12 Months]
The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
Secondary Outcome Measures
- Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation [12 Months]
The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 12 months.
- LV reverse remodeling (LVESVi on echocardiography) [12 Months]
The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 12 months.
- LVEF [12 Months]
The secondary outcome measure is LVEF as measured by echocardiography at 12 months.
- HF Morbidity [12 Months]
The secondary outcome measure is HF morbidity at 12 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with NYHA class II-IVa HF symptoms and are on diuretic therapy
-
LVEF > 35% (stratify by LVEF 36-49% and LVEF ≥ 50%), and recovered LVEF (previously LVEF ≤ 35%, but improved to LVEF > 35% with medical therapy)
-
Patients with LVEF ≥ 40% must also have either left atrial volume index (LAVI) > 34 mL/m2 or LV mass index (LVMI) ≥ 115 g/m2 for males and ≥ 95 g/m2 for female
-
Sinus rhythm (can have paroxysmal atrial fibrillation)
-
LBBB and QRS duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-QRS notching or slurring in ≥ 2 leads
-
NT-proBNP ≥ 600 pg/ml or BNP level ≥ 120 pg/ml on stable medical therapy
-
Appropriate pharmacological treatment of HF and co-morbidities.
-
Stable diuretic and other HF medications for at least four weeks
Exclusion Criteria:
-
Patients with permanent atrial fibrillation
-
Patients with clinical indication for pacemaker or Implantable Cardioverter-Defibrillator
-
Serum creatinine >180 μmol/L; or estimated glomerular filtration rate [eGFR] ≤30 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease formula
-
In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
-
Acute coronary syndrome (including MI) <4 weeks
-
Coronary revascularization (CABG or PCI) < 3 months
-
Uncorrected or uncorrectable primary valvular disease
-
TAVI < 3 months
-
Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
-
Severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm Hg))
-
Expected to undergo cardiac transplantation within one year (status I)
-
Patients with a life expectancy of less than one year from non-cardiac cause.
-
Patients included in other clinical trials that will affect the objectives of this study
-
Those unable or unwilling to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre | London | Ontario | Canada |
Sponsors and Collaborators
- Anthony Tang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTO 3310