Implant of the device for Cardiac Contractility Modulation (CCM) Therapy in Heart Failure and Lamin A/C Gene Mutation and Laminopathy - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Antonio D'Onofrio, MD
Phone Number: +39 0817062605
Email: donofrioant1@gmail.com

Study Contact Backup

Name: Giuliano D'Alterio, MD
Phone Number: +39 0817062605
Email: gdalterio@libero.it

Study Locations

Italy
- - Naples, Italy, 80131
    - Recruiting
    - AO dei Colli - Monaldi Hospital
    - Contact:
      
      Antonio D'Onofrio, MD
      
      Phone Number: +39 0817062605
      
      Email: donofrioant1@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of QoL Time Frame: 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.	12 months
Reduction of HF Hospitalizations and Emergency Ward accesses Time Frame: 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	12 months
Improvement of Fuctional Capacity Time Frame: 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess of HF biomarkers trends Time Frame: 12 months	Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monaldi Hospital

Investigators

Study Director: Antonio D'Onofrio, MD, AO dei Colli - Monaldi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 15, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)