Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Heart Failure Clinical Trial

— CARDILAM-CCM  

Official title:

Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904393
• Other study ID #: CCM-002Mon
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2021
• Source: Monaldi Hospital
• Contact: Antonio D'Onofrio, MD
• Phone: +39 0817062605
• Email: donofrioant1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational, retrospective registry with acute and chronic endpoints

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Lamin A/C Gene Mutation

Intervention

Device:
• Implant of the device for Cardiac Contractility Modulation (CCM) Therapy
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

Locations

Country	Name	City	State
Italy	AO dei Colli - Monaldi Hospital	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Monaldi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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	12 months
Primary	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	12 months
Secondary	Assess of HF biomarkers trends	Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline	12 months