Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy, non responders, MultiPoint Pacing (MPP)
Brief summary
This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).
Detailed description
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP. This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period. Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.
Interventions
DEVICECardiac Resynchronization Therapy with MultiPoint Pacing
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients implanted with a St. Jude Medical CRT-D system with MPP capability * Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements * NT pro-BNP levels equal to or greater than 500 pg/ml.
Exclusion criteria
* History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months. * Atrial fibrillation with noncontrolled heart rate * Need for intravenous inotropic support for CHF * Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months * Undergone a cardiac transplantation * Currently participating in any other clinical investigation * Life expectancy \< 12 months due to a disorder other than CHF * Inability to comply with the follow-up procedures * Patients who are or may potentially be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP) | Baseline. 3-Month. 6-Month. | Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Hospitalizations | 3-Month. 6-Month. | — |
| New York Heart Association (NYHA) Class changes | Baseline. 3-Month. 6-Month. | — |
| Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire | Baseline. 3-Month. 6-Month. | — |
| Echocardiographic changes | Baseline. 3-Month. 6-Month. | Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity. |
| Appropriate device interventions (anti-tachycardia pacing or shock) | 3-Month. 6-Month. | — |
| Changes in Neurohormonal Activation | Baseline. 3-Month. 6-Month. | Renin, Aldosteron, Norepinephrine, Endothelin-1. |
| Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]). | 3-Month. 6-Month. | — |
| Flow-mediated vasodilation | Baseline. 3-month. 6-month | Differences in FMD between groups |
| Packer's clinical composite score | Baseline. 3-month. 6-month. | Distribution of improved, unchanged and worsened patients as defined per Packer's clinical composite score |
| 6-Minute-Walking-Distance | Baseline. 3 Month. 6 Month. | The distance walked by subjects during a 6 minutes walking test |
| Phrenic Nerve Complication Free Rate | 3-Month. 6-Month. | — |
Countries
Italy
Outcome results
None listed