ClinicalTrials.gg
WithdrawnNCT04143997Updated Aug 23, 2024

Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery

An observational study in Peripartum Cardiomyopathy and Diastolic Dysfunction, sponsored by Medical College of Wisconsin. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Medical College of Wisconsin · Observational

Why this study was withdrawn
No pt enrolled
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Peripartum Cardiomyopathy
  • Diastolic Dysfunction
03

In context

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 546 studies on the registry; 120 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 57 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.

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.

Inclusion criteria

  1. Female.
  2. Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis.
  3. Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
  4. Documented recovered of LV systolic performance defined as LVEF > 50%.

Exclusion criteria

Exclusion Criteria:

  1. No pregnancy history.
  2. No diagnosis of peripartum cardiomyopathy.
  3. Non-recovery of LV systolic function.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: A clinical Transthoracic echocardiogram

Interventions

  • Diagnostic testA clinical Transthoracic echocardiogram

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: January 1, 2014 through September 1, 2019

07

Study locations

1 site
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04143997
Responsible party
Sponsor
First posted
Oct 30, 2019
Start date
Nov 1, 2019
Primary completion
Jan 29, 2021 (estimated)
Completion
Jan 29, 2021 (estimated)
Last update
Aug 23, 2024

Study contacts

Sarah Thordsen, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion