LaminopathyCARDILAM-CCMNCT04904393
Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry
An observational study of Laminopathy and Lamin A/C Gene Mutation, run by Monaldi Hospital at 1 site in Italy.
Trial summary
Observational, retrospective registry with acute and chronic endpoints Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laminopathy, Lamin A/C Gene Mutation, Heart Failure
- What is being tested?
- Implant of the device for Cardiac Contractility Modulation (CCM) Therapy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AO dei Colli - Monaldi Hospital
Naples, 80131
Antonio D'Onofrio, MD, +39 0817062605, donofrioant1@gmail.com
About this study
Official title: Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy
Observational, retrospective registry with acute and chronic endpoints
Read the 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
- Conditions
- Laminopathy, Lamin A/C Gene Mutation, Heart Failure
- Being tested
- Implant of the device for Cardiac Contractility Modulation (CCM) Therapy
- Keywords
- Heart Failure, Cardiac Contyractility Modulation, Quality of Life
- Medical subject headings
- Laminopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (1)
Assess of HF biomarkers trends
Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start8 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaminopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monaldi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio D'Onofrio, Monaldi Hospital
- Investigators
- Antonio D'Onofrio, MD, Study director, Ao dei Colli - Monaldi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904393
- Sponsor's protocol ID
- CCM-002Mon
- Acronym
- CARDILAM-CCM
- Status last verified
- May 2021
- First submitted
- 15 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy
- ClinicalTrials.gov ID
- NCT04904393
- Acronym / sponsor ID
- CARDILAM-CCM / CCM-002Mon
- Conditions
- Laminopathy, Lamin A/C Gene Mutation, Heart Failure
- Keywords
- Heart Failure, Cardiac Contyractility Modulation, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Monaldi HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant of the device for Cardiac Contractility Modulation (CCM) TherapyThe 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 | Device | – |
Primary outcome
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.
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
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
1 secondary outcome
Assess of HF biomarkers trends
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio D'Onofrio, MD study director
Ao dei Colli - Monaldi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laminopathy and Lamin A/C Gene Mutation, run by Monaldi Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio D'Onofrio, MD (+39 0817062605, donofrioant1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of QoL (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.