Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Monaldi Hospital20 enrolled

Overview

Observational, retrospective registry with acute and chronic endpoints

This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations

Study Type

OBSERVATIONAL

Enrollment

Conditions

Laminopathy Lamin A/C Gene Mutation Heart Failure

Interventions

Implant of the device for Cardiac Contractility Modulation (CCM) TherapyDEVICE

The intervention is an implant of CCM therapy devices and it is similar to conventional dual chamber cardiac devices with only difference of to insert n 2 leads fixed in right ventricular septum

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-pregnant female, aged 18 or older; * chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker); * Appropriate and optimized medical therapy; * Patient signed and dated informed consent form at enrollment; * life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis Exclusion Criteria: * absence of venous access available for implant; * contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale); * pregnant patients

Locations (1)

AO dei Colli - Monaldi Hospital

Naples, Italy

RECRUITING

Outcomes

Primary Outcomes

Improvement of QoL

Evaluation of the effect of CCM therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline.

Time frame: 12 months

Reduction of HF Hospitalizations and Emergency Ward accesses

Reduction of HF Hospitalizations and Emergency Ward accesses collected during the FU post implant of CCM device compared to number of Hospitalizations and Emergenncy Ward accesses collected 1 year before the implant of CCM therapy device

Time frame: 12 months

Improvement of Fuctional Capacity

Evaluation of the impact of CCM therapy on Functional Capacity evaluated from the gain of the distance travelled in the 6MWT at FU post implant of CCM therapy device compared to baseline

Time frame: 12 months

Secondary Outcomes

Assess of HF biomarkers trends

Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline

Time frame: 12 months

Central Contacts

Antonio D'Onofrio, MD

CONTACT

+39 0817062605 donofrioant1@gmail.com

Giuliano D'Alterio, MD

CONTACT

+39 0817062605 gdalterio@libero.it

Data from ClinicalTrials.gov

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