Peripartum CardiomyopathyNCT04143997
Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery
An observational study of Peripartum Cardiomyopathy and Diastolic Dysfunction, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripartum Cardiomyopathy, Diastolic Dysfunction
- What is being tested?
- A clinical Transthoracic echocardiogram
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 29 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
Who may be able to join
- Female.
- Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis.
- Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
- Documented recovered of LV systolic performance defined as LVEF > 50%.
Who cannot join
- No pregnancy history.
- No diagnosis of peripartum cardiomyopathy.
- Non-recovery of LV systolic function.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function.
- Conditions
- Peripartum Cardiomyopathy, Diastolic Dysfunction
- Being tested
- A clinical Transthoracic echocardiogram
- Medical subject headings
- Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A clinical Transthoracic echocardiogramDiagnostic test
A previously clinically completed transthoracic echocardiogram will be utilized to assess for diastolic dysfunction in the presence of normal systolic function for patients with previously diagnosed peripartum cardiomyopathy.
| Study group | Role | What they receive |
|---|---|---|
| PPCM with Diastolic Dysfunction & Normal Systolic Function | The patient population examined will include patients diagnosed with peripartum cardiomyopathy who have diastolic dysfunction and normal systolic function. Receives: Diagnostic Test: A clinical Transthoracic echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report the incidence of diastolic dysfunction in peripartum cardiomyopathy patients with full systolic function recovery
Investigators will review and report incidence of remaining diastolic dysfunction for local patient population which have recovered systolic function.
Measured: January 1, 2014 through September 1, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Nov 2019
- Primary completion29 Jan 2021 (estimated)
- Study completion29 Jan 2021 (estimated)
Why it stopped: No pt enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum CardiomyopathyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Thordsen, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143997
- Sponsor's protocol ID
- PRO00036227
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery
- ClinicalTrials.gov ID
- NCT04143997
- Acronym / sponsor ID
- PRO00036227
- Conditions
- Peripartum Cardiomyopathy, Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No pt enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 29 Jan 2021 (estimated)
- Study completion
- 29 Jan 2021 (estimated)
- First posted
- 30 Oct 2019 (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.
The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPCM with Diastolic Dysfunction & Normal Systolic Function | – | Diagnostic Test: A clinical Transthoracic echocardiogramThe patient population examined will include patients diagnosed with peripartum cardiomyopathy who have diastolic dysfunction and normal systolic function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
Key inclusion criteria (4 listed)
- Female.
- Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis.
- Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
- Documented recovered of LV systolic performance defined as LVEF > 50%.
Key exclusion criteria (3 listed)
- No pregnancy history.
- No diagnosis of peripartum cardiomyopathy.
- Non-recovery of LV systolic function.
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 |
|---|---|---|
| A clinical Transthoracic echocardiogramA previously clinically completed transthoracic echocardiogram will be utilized to assess for diastolic dysfunction in the presence of normal systolic function for patients with previously diagnosed peripartum cardiomyopathy. | Diagnostic test | PPCM with Diastolic Dysfunction & Normal Systolic Function |
Primary outcome
Report the incidence of diastolic dysfunction in peripartum cardiomyopathy patients with full systolic function recovery
Time frame: January 1, 2014 through September 1, 2019
Investigators will review and report incidence of remaining diastolic dysfunction for local patient population which have recovered systolic function.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Sarah Thordsen, MD principal investigator
Medical College of Wisconsin
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 and Diastolic Dysfunction, run by Medical College of Wisconsin at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 23 Aug 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report the incidence of diastolic dysfunction in peripartum cardiomyopathy patients with full systolic function recovery (time frame: January 1, 2014 through September 1, 2019). 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 23 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.