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Taurine in Peripartum Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907267
Recruitment Status : Completed
First Posted : April 8, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Peripartum Cardiomyopathy Drug: Taurine Solution Dietary Supplement: Normal Saline Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
Drug Information available for: Taurine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Taurine Drug: Taurine Solution
Taurine Solution
Placebo Comparator: Saline Dietary Supplement: Normal Saline
Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. improvement of the left ventricular ejection fraction >10 % [ Time Frame: 1 week ]
    improvement of the left ventricular ejection fraction >10 %


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripartum Cardiomyopathy

Exclusion Criteria:

  • Other identifiable cause for heart failure
  • low LVEF ≤ 25%
  • sepsis
  • autoimmune disease
  • severe chronic disease
  • malignancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907267


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
More Information
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Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03907267    
Other Study ID Numbers: AS1755
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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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
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases