Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

• Conditions: Lamin A/C Gene Mutation; Heart Failure; Laminopathy

• Registration Number: NCT04904393
• Lead Sponsor: Monaldi Hospital

Brief Summary

Observational, retrospective registry with acute and chronic endpoints

Detailed Description

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 Timeline

• Study Start: 2021-03-08
• Status Verified: 2021-05
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of QoL	12 months	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.
Reduction of HF Hospitalizations and Emergency Ward accesses	12 months	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
Improvement of Fuctional Capacity	12 months	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

Secondary Outcome Measures

Name	Time	Method
Assess of HF biomarkers trends	12 months	Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline

Trial Locations

Locations (1)

AO dei Colli - Monaldi Hospital; 🇮🇹 Naples, Italy