An observational study in Laminopathy, Lamin A/C Gene Mutation and Heart Failure, sponsored by Monaldi Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Monaldi Hospital · Observational
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Among 449 studies in Heart Failure with a site in Italy — 111 open to participants now, 130 under way, 18 of them phase 3. Heart Failure · Italy.
Among the 449 studies in Heart Failure with a site in Italy, this one is the 148th largest by planned enrollment of the 152 observational ones that give a count, is one of 22 that started in 2021, is one of 155 observational ones, and was the 293rd registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →111 of the 449 studies in Heart Failure with a site in Italy are open now. Recruiting first, the newest first:
Niguarda Hospital · Sites in Italy
Ages 18+
AstraZeneca · Sites in Italy, United States, Argentina and 29 more countries
Ages 18+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+
Bayer · Sites in Italy, United States, Argentina and 20 more countries
Ages up to 18
Biotronik SE & Co. KG · Sites in Italy, Australia, Austria and 10 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
449 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 48 · Phase 3 85 · Phase 4 36
First in 1983; this study’s year is marked. 22 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Median enrollment 200 across the 292 interventional studies, 353 across the 152 observational. Of the 252 that completed or were terminated, 91 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
205 of 449 have an industry lead sponsor. The 10 most frequent:
Monaldi Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Monaldi Hospital has 3 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
36 of the studies in Heart Failure with a site in Italy that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
| NCT03775161Vectorious Medical Technologies Ltd.V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure | 2026-12 |
| NCT03994874Iperboreal Pharma SrlPeritoneal Ultrafiltration in Cardio Renal Syndrome. | 2026-12 |
Add all 36 to your calendar (.ics) → With an account.
Among the 449 studies in Heart Failure with a site in Italy, from their registry updates:
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Observational, retrospective registry with acute and chronic endpoints
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
Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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
Time frame: 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
Time frame: 12 months
Assess of HF biomarkers trends
Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline
Time frame: 12 months
Started Mar 2021 (actual). Primary completion is estimated for Dec 2022, 21 months after the start.
Of 794 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 21 months is below that.
Counting every sponsor, half of 976 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Monaldi Hospital