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

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 Overview

• Status: Withdrawn
• Conditions: Diastolic Dysfunction; Peripartum Cardiomyopathy
• Intervention / Treatment: Diagnostic test: A clinical Transthoracic echocardiogram

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Medical College of Wisconsin
• Investigators: Principal Investigator: Sarah Thordsen, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): January 29, 2021
• Study Completion (Estimated): January 29, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: PRO00036227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No