Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Failure Lamin A/C Gene Mutation Laminopathy

Keywords

Heart FailureCardiac Contyractility ModulationQuality of Life

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (1)

Assess of HF biomarkers trends
12 months

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Male or non-pregnant female, aged 18 or older;

Sponsors & Collaborators

Monaldi Hospital
Otherlead

Study Sites (1)

AO dei Colli - Monaldi Hospital

Naples, 80131, Italy

RECRUITING

Antonio D'Onofrio, MDCONTACT+39 0817062605 donofrioant1@gmail.com

MeSH Terms

Conditions

LaminopathiesHeart Failure

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart DiseasesCardiovascular Diseases

Study Officials

Antonio D'Onofrio, MD
Ao dei Colli - Monaldi Hospital
STUDY DIRECTOR

Central Study Contacts

Antonio D'Onofrio, MD

CONTACT

+39 0817062605 donofrioant1@gmail.com

Giuliano D'Alterio, MD

CONTACT

+39 0817062605

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie

Study Record Dates

First Submitted

May 15, 2021

First Posted

May 27, 2021

Study Start

March 8, 2021

Actual (reported)

Primary Completion

December 31, 2022

Estimated (date passed)

Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations