NCT04143997

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

October 28, 2019

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

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.

    January 1, 2014 through September 1, 2019

Study Arms (1)

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

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.

PPCM with Diastolic Dysfunction & Normal Systolic Function

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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%.

You may not qualify if:

  • No pregnancy history.
  • No diagnosis of peripartum cardiomyopathy.
  • Non-recovery of LV systolic function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Condition Hierarchy (Ancestors)

Pregnancy Complications, CardiovascularPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Sarah Thordsen, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

November 1, 2019

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations