Peripartum CardiomyopathyPhase 2/3NCT03907267
Taurine in Peripartum Cardiomyopathy
A Phase 2/3 study testing Taurine Solution and Normal Saline in people with Peripartum Cardiomyopathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Peripartum Cardiomyopathy
- What is being tested?
- Taurine Solution and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 1 Jan 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Peripartum Cardiomyopathy
Who cannot join
- Other identifiable cause for heart failure
- low LVEF ≤ 25%
- sepsis
- autoimmune disease
- severe chronic disease
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy
Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy
- Conditions
- Peripartum Cardiomyopathy
- Being tested
- Taurine Solution, Normal Saline
- Medical subject headings
- Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine SolutionDrug
Taurine Solution
Normal SalineDietary supplement
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Taurine | Experimental | Not described Receives: Drug: Taurine Solution |
| Saline | Placebo comparator | Not described Receives: Dietary Supplement: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of the left ventricular ejection fraction >10 %
improvement of the left ventricular ejection fraction >10 %
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Jan 2015
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907267
- Sponsor's protocol ID
- AS1755
- Status last verified
- Jan 2020
- First submitted
- 5 Apr 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03907267
- Acronym / sponsor ID
- AS1755
- Conditions
- Peripartum Cardiomyopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurine | Experimental | Drug: Taurine Solution |
| Saline | Placebo comparator | Dietary Supplement: Normal Saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Peripartum Cardiomyopathy
Key exclusion criteria (6 listed)
- Other identifiable cause for heart failure
- low LVEF ≤ 25%
- sepsis
- autoimmune disease
- severe chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine SolutionTaurine Solution | Drug | Taurine |
| Normal SalineNormal Saline | Dietary supplement | Saline |
Primary outcome
improvement of the left ventricular ejection fraction >10 %
Time frame: 1 week
improvement of the left ventricular ejection fraction >10 %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Taurine Solution and Normal Saline in people with Peripartum Cardiomyopathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of the left ventricular ejection fraction >10 % (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.