Peripartum CardiomyopathyPPCMREGISTRYNCT05878041
Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.
An observational study of Peripartum Cardiomyopathy, run by Federico II University at 1 site in Italy.
Trial summary
Peripartum cardiomyopathy (PPCM) is a rare, severe and potentially life-threatening disorder of largely unknown etiology and pathophysiology, with unexplained geographical differences and heterogeneous presentation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peripartum Cardiomyopathy
- What is being tested?
- Molecular and genetic screening
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2024to 19 May 2026
- How long will I take part?
- 6 Months
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosis of PPCM will be defined according to the ESC guidelines as: (i) the development of the disease in the last month of pregnancy or within 5 months of delivery; (i) absence of an identifiable cause of heart failure; (iii) absence of recognizable heart disease before the last month of pregnancy; (iv) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (Eur Heart J 2018;34: 3165; Eur Heart J 2021; 42: 3599). Like other rare diseases, correct diagnosis of PPCM is mostly based on exclusion criteria; however, the differential diagnosis between PPCM, pre-existing chronic heart failure, and other causes of acute heart failure in the peripartum scenario remains challenging.
Who may be able to join
- Development of HF signs or symptoms in the last month of pregnancy or within 5 months of delivery;
- Left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (LVEF< 45 %) in the last month of pregnancy or within 5 months of delivery.
Who cannot join
- Presence of any identifiable cause of HF;
- Presence of recognizable heart disease before the last month of pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Federico II University Hospital
Naples, 80131
Gabriele Saccone
About this study
Official title: Creation of a Multicenter National Registry for Peripartum Cardiomyopathy: a Wide, Multidisciplinary and Translational Perspective to Achieve Personalized Medicine for a Rare Disease in Women
Peripartum cardiomyopathy (PPCM) is a rare, severe and potentially life-threatening disorder of largely unknown etiology and pathophysiology, with unexplained geographical differences and heterogeneous presentation. Investigators hypothesize that a network-based multidisciplinary strategy integrating clinical and molecular phenotyping of PPCM patients might anticipate diagnosis, optimize treatments, and identify novel mechanisms to achieve the unmet goal of personalized medicine.
Read the detailed description
Specific aims of this study are: a) to create a multicenter pilot registry of PPCM in different areas in Italy to assess incidence and prevalence of this rare disease, associated comorbidities and risk factors. b) to deeply characterize identified PPCM patients through clinical, imaging, genetic, biochemical, and molecular phenotyping. c) to gain novel mechanistic information on PPCM by performing deep clinical and molecular phenotyping in available biobanks samples of patients with PPCM and healthy controls.
- Conditions
- Peripartum Cardiomyopathy
- Being tested
- Molecular and genetic screening
- Medical subject headings
- Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular and genetic screeningDiagnostic test
Molecular and genetic screening
| Study group | Role | What they receive |
|---|---|---|
| Peripartum cardiomyopathy | Diagnosis of Peripartum cardiomyopathy (PPCM) will be defined according to the ESC guidelines as: (i) the development of the disease in the last month of pregnancy or within 5 months of delivery; (i) absence of an identifiable cause of heart failure; (iii) absence of recognizable heart disease before the last month of pregnancy; (iv) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria. Receives: Diagnostic Test: Molecular and genetic screening | |
| Healthy pregnant volunteers | Healthy pregnant women Receives: Diagnostic Test: Molecular and genetic screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or hospitalization due to heart failure
Death or hospitalization due to heart failure during the follow-up period
Measured: 0-6 months
Development of significant cardiac arrhythmias
New onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period
Measured: 0-6 months
Secondary outcomes (1)
Left ventricular dysfunction
Left ventricular % ejection fraction during the follow-up period
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start21 Feb 2024
- Primary completion19 Feb 2025 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripartum CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, San Giuseppe Moscati Hospital
- Responsible party
- Principal investigator, Cinzia Perrino, Federico II University
- Investigators
- Cinzia Perrino, MD pHD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878041
- Sponsor's protocol ID
- PNRR-MR1-2022-12376858
- Acronym
- PPCMREGISTRY
- Status last verified
- Mar 2024
- First submitted
- 18 May 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilardi F, Manzo R, Peretto G, Lanni F, Peano V, Loffredo FS, Masarone D, Gerardi D, di Maio S, Bardi L, Licciardi M, Montali N, Pezzullo E, Di Lorenzo E, Stabile E, Battaglia C, Calanducci M, Bifulco G, Anastasia L, Carusone F, Cascone A, Di Santo M, Cavoretto PI, D'Alconzo D, Palmentieri A, Carotenuto M, Di Spiezio Sardo A, Ioele D, Paolillo R, Polese P, Saccone G, Esposito G, Chieffo A, Perrino C. Clinical presentation and echocardiographic characteristics of women with peripartum cardiomyopathy: Insights from the Italian Multicentre Registry. Int J Cardiol. 2026 Jan 1;442:133866. doi: 10.1016/j.ijcard.2025.133866. Epub 2025 Sep 4.
PubMed 40914510
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Multicenter National Registry for Peripartum Cardiomyopathy: a Wide, Multidisciplinary and Translational Perspective to Achieve Personalized Medicine for a Rare Disease in Women
- ClinicalTrials.gov ID
- NCT05878041
- Acronym / sponsor ID
- PPCMREGISTRY / PNRR-MR1-2022-12376858
- Conditions
- Peripartum Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, San Giuseppe Moscati Hospital
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 19 Feb 2025 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 26 May 2023 (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.
Peripartum cardiomyopathy (PPCM) is a rare, severe and potentially life-threatening disorder of largely unknown etiology and pathophysiology, with unexplained geographical differences and heterogeneous presentation. Investigators hypothesize that a network-based multidisciplinary strategy integrating clinical and molecular phenotyping of PPCM patients might anticipate diagnosis, optimize treatments, and identify novel mechanisms to achieve the unmet goal of personalized medicine.
Detailed description
Specific aims of this study are: a) to create a multicenter pilot registry of PPCM in different areas in Italy to assess incidence and prevalence of this rare disease, associated comorbidities and risk factors. b) to deeply characterize identified PPCM patients through clinical, imaging, genetic, biochemical, and molecular phenotyping. c) to gain novel mechanistic information on PPCM by performing deep clinical and molecular phenotyping in available biobanks samples of patients with PPCM and healthy controls.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripartum cardiomyopathy | – | Diagnostic Test: Molecular and genetic screeningDiagnosis of Peripartum cardiomyopathy (PPCM) will be defined according to the ESC guidelines as: (i) the development of the disease in the last month of pregnancy or within 5 months of delivery; (i) absence of an identifiable cause of heart failure; (iii) absence of recognizable heart disease before the last month of pregnancy; (iv) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria. |
| Healthy pregnant volunteers | – | Diagnostic Test: Molecular and genetic screeningHealthy pregnant women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of PPCM will be defined according to the ESC guidelines as: (i) the development of the disease in the last month of pregnancy or within 5 months of delivery; (i) absence of an identifiable cause of heart failure; (iii) absence of recognizable heart disease before the last month of pregnancy; (iv) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (Eur Heart J 2018;34: 3165; Eur Heart J 2021; 42: 3599). Like other rare diseases, correct diagnosis of PPCM is mostly based on exclusion criteria; however, the differential diagnosis between PPCM, pre-existing chronic heart failure, and other causes of acute heart failure in the peripartum scenario remains challenging.
Key inclusion criteria (2 listed)
- Development of HF signs or symptoms in the last month of pregnancy or within 5 months of delivery;
- Left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (LVEF< 45 %) in the last month of pregnancy or within 5 months of delivery.
Key exclusion criteria (2 listed)
- Presence of any identifiable cause of HF;
- Presence of recognizable heart disease before the last month of pregnancy.
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 |
|---|---|---|
| Molecular and genetic screeningMolecular and genetic screening | Diagnostic test | Healthy pregnant volunteers, Peripartum cardiomyopathy |
Primary outcome
Death or hospitalization due to heart failure
Time frame: 0-6 months
Death or hospitalization due to heart failure during the follow-up period
Development of significant cardiac arrhythmias
Time frame: 0-6 months
New onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period
1 secondary outcome
Left ventricular dysfunction
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 40914510Ilardi F, Manzo R, Peretto G, Lanni F, Peano V, Loffredo FS, Masarone D, Gerardi D, di Maio S, Bardi L, Licciardi M, Montali N, Pezzullo E, Di Lorenzo E, Stabile E, Battaglia C, Calanducci M, Bifulco G, Anastasia L, Carusone F, Cascone A, Di Santo M, Cavoretto PI, D'Alconzo D, Palmentieri A, Carotenuto M, Di Spiezio Sardo A, Ioele D, Paolillo R, Polese P, Saccone G, Esposito G, Chieffo A, Perrino C. Clinical presentation and echocardiographic characteristics of women with peripartum cardiomyopathy: Insights from the Italian Multicentre Registry. Int J Cardiol. 2026 Jan 1;442:133866. doi: 10.1016/j.ijcard.2025.133866. Epub 2025 Sep 4.
- Individual participant dataSharing planned: No
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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.
Cinzia Perrino, MD pHD principal investigator
Federico II University
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 Peripartum Cardiomyopathy, run by Federico II University 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 2 inclusion and 2 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 21 Mar 2024. 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 Cinzia Perrino (+39 081 7462223, perrino@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or hospitalization due to heart failure (time frame: 0-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878041, which also lists 1 linked publication.
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 21 Mar 2024.