Heart Failure Clinical Trial
Official title:
Multipolar Pacing by Cardiac Resynchronization Therapy With a Defibrillator as Treatment in Type 2 Diabetes Mellitus Failing Heart Patients: Impact on Responders Rate, and Clinical Outcomes.
Verified date | April 2017 |
Source | Second University of Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Type 2 Diabetes Mellitus (T2DM) is a multi factorial disease, affecting clinical
outcomes in failing heart (HF) patients treated by Cardiac Resynchronization Therapy with a
defibrillator (CRT-d).
Methods: One hundred and ninety five T2DM patients will receive a CRT-d treatment. Randomly
the study population will receive a CRT-d via multipolar left ventricle (LV) lead pacing (n
99 as Multipolar group), v/s a CRT-d via bipolar LV pacing (n 96, as Bipolar group). These
patients will be followed by clinical, and instrumental assessment, and telemetric device
control at follow up. Study design will be to evaluate, in failing heart T2DM patients,
cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations
for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and
re-intervention for LV catheter re-positioning), comparing multipolar CRT-d v/s bipolar
CRT-d group of patients at follow up.
Status | Completed |
Enrollment | 190 |
Est. completion date | September 1, 2015 |
Est. primary completion date | September 1, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: T2DM patients with stable chronic heart failure, New York Heart Association (NYHA) functional class II or III, left bundle branch block, severe left ventricle ejection fraction reduction (LVEF < 35%), stable sinus rhythm, candidates to receive a CRT-d treatment Exclusion Criteria: age <18 or >75 years, ejection fraction >35%, previous implantable cardioverter defibrillator (ICD), CRT-d and/or pacemaker implant, absence of informed patient consent, and any condition that would make survival for 1 year unlikely. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Celestino Sardu |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phrenic nerve stimulation episodes | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of Phrenic nerve stimulation episodes (PNS). PNS were assessed by left ventricle pacing leads threshold by a standard protocol at CRT-d implant, and during all follow up durations by CRT-d devices interrogations. In case of PNS diagnosis during follow up, by patients symptoms assessment (phrenic simulations during CRTd pacing), and confirmed by devices interrogations, and physician ambulatory diagnosis, we reached the best left ventricle lead pacing configuration to solve PNS. | 24 months | |
Primary | Left Ventricle (LV) leads dislodgments | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of LV leads dislodgments, as confirmed by the movement of the catheter into and out of the coronary sinus implantation vessel site, and then causing a change in the catheter tip location. It was diagnosed by patients clinical symptoms, hospital admissions schedules, hospital discharge schedules, and during medical interrogation at follow up visits, and was confirmed by radiographic biplane projections assessment. | 24 months | |
Primary | Interventions to re-position LV leads | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of interventions done after the first CRT-d implant to re-position LV leads in case of LV leads dislodgments. This endpoint was evaluated by hospital admissions schedules, hospital discharge schedules, and medical interrogations at follow up visits. These interventions were done in case of LV catheter dislodgments. | 24 months | |
Primary | Hospitalization rate for HF worsening | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of hospitalization rate for HF worsening. Hospitalization rate was reported during telephonic interviews, by hospital admissions schedules, hospital discharge schedules, and during medical interrogation at follow up visits. | 24 months | |
Primary | Cardiac deaths | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of Cardiac deaths. Cardiac deaths were evaluated during office follow up visits 10 days after clinical discharge, and after 6th and 12th months by the treating physician, by telephonic interview, hospital admission, and discharge schedules. | 24 months | |
Primary | All cause deaths. | As primary endpoints we monitored CRT-d effect in multipolar CRT-d patients v/s bipolar CRT-d in terms of all cause deaths. Alla cause deaths were evaluated during office follow up visits 10 days after clinical discharge, and after 6th and 12th months by the treating physician, by telephonic interview, hospital admission, and discharge schedules. | 24 months |
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