Tetralogy of FallotPhase 4NCT01971593
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
A Phase 4 study testing Eplerenone in people with Tetralogy of Fallot and Transposition of the Great Vessels With an Arterial Switch, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Hypothesis: By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
- Patient followed regularly at Washington University-affiliated institution
- If female, willing to use 2 forms of contraception including one barrier method during protocol
Who cannot join
- GFR <30 ml/min
- Potassium >5.0 mmol/L
- Unable or unwilling to comply with study protocol
- Use of potassium sparing diuretics
- Use of an aldosterone blocker currently or previously
- Known intolerance of eplerenone or aldosterone blockade
- Pregnant, breastfeeding, or actively trying to get pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Hypothesis:
By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.
Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.
- Conditions
- Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
- Being tested
- Eplerenone
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Inspra
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone after drug free period | Other | Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period Receives: Drug: Eplerenone |
| Eplerenone before drug free period | Other | Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procollagen N-terminal Peptide 1
Measured: Baseline, 6 months and 12 months from eplerenone administration
Procollagen III N-Terminal Peptide
Measured: Baseline, 6 months and 12 months from eplerenone administration
Galectin 3
Measured: Baseline, 6 months and 12 months from eplerenone administration
Secondary outcomes (2)
6 Minute Walk
Measured: Baseline, 6 months, 12 months from eplerenone administration
Quality of Life
Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function
Measured: Baseline, 6 months, 12 months from eplerenone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionJun 2016
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Ari Cedars, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971593
- Sponsor's protocol ID
- WI170964
- Status last verified
- Apr 2018
- First submitted
- 23 Oct 2013
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01971593
- Acronym / sponsor ID
- WI170964
- Conditions
- Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Posted 4 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:
By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.
Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone after drug free period | Other | Drug: EplerenonePatients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period |
| Eplerenone before drug free period | Other | Drug: EplerenonePatients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
- Patient followed regularly at Washington University-affiliated institution
- If female, willing to use 2 forms of contraception including one barrier method during protocol
Key exclusion criteria (7 listed)
- GFR <30 ml/min
- Potassium >5.0 mmol/L
- Unable or unwilling to comply with study protocol
- Use of potassium sparing diuretics
- Use of an aldosterone blocker currently or previously
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 |
|---|---|---|
| EplerenoneAlso: Inspra | Drug | Eplerenone after drug free period, Eplerenone before drug free period |
Primary outcome
Procollagen N-terminal Peptide 1
Time frame: Baseline, 6 months and 12 months from eplerenone administration
Procollagen III N-Terminal Peptide
Time frame: Baseline, 6 months and 12 months from eplerenone administration
Galectin 3
Time frame: Baseline, 6 months and 12 months from eplerenone administration
2 secondary outcomes
6 Minute Walk
Time frame: Baseline, 6 months, 12 months from eplerenone administration
Quality of Life
Time frame: Baseline, 6 months, 12 months from eplerenone administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
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 4 study testing Eplerenone in people with Tetralogy of Fallot and Transposition of the Great Vessels With an Arterial Switch, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 May 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procollagen N-terminal Peptide 1 (time frame: Baseline, 6 months and 12 months from eplerenone administration). The study lists 3 primary outcomes in all. 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 4 May 2018.