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

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04143997
• Other study ID #: PRO00036227
• Status: Withdrawn
• Start date: November 1, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: January 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Diastolic Dysfunction
• Peripartum Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Sarah Thordsen	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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