NCT03907267

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4.9 years

First QC Date

April 5, 2019

Last Update Submit

January 26, 2020

Conditions

Peripartum Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • improvement of the left ventricular ejection fraction >10 %

    improvement of the left ventricular ejection fraction \>10 %

    1 week

Study Arms (2)

Taurine

EXPERIMENTAL
Drug: Taurine Solution

Saline

PLACEBO COMPARATOR
Dietary Supplement: Normal Saline

Interventions

Taurine SolutionDRUG

Taurine Solution

Taurine
Normal SalineDIETARY_SUPPLEMENT

Normal Saline

Saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Peripartum Cardiomyopathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)