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Taurine in Peripartum Cardiomyopathy

Primary Purpose

Peripartum Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Taurine Solution
Normal Saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripartum Cardiomyopathy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Peripartum Cardiomyopathy

Exclusion Criteria:

  • Other identifiable cause for heart failure
  • low LVEF ≤ 25%
  • sepsis
  • autoimmune disease
  • severe chronic disease
  • malignancy

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Taurine

Saline

Arm Description

Outcomes

Primary Outcome Measures

improvement of the left ventricular ejection fraction >10 %
improvement of the left ventricular ejection fraction >10 %

Secondary Outcome Measures

Full Information

First Posted
April 5, 2019
Last Updated
January 26, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03907267
Brief Title
Taurine in Peripartum Cardiomyopathy
Official Title
Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripartum Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taurine
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Taurine Solution
Intervention Description
Taurine Solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
improvement of the left ventricular ejection fraction >10 %
Description
improvement of the left ventricular ejection fraction >10 %
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Peripartum Cardiomyopathy Exclusion Criteria: Other identifiable cause for heart failure low LVEF ≤ 25% sepsis autoimmune disease severe chronic disease malignancy
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Taurine in Peripartum Cardiomyopathy

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