Congenital Heart DiseasePhase 2NCT01069510
Spironolactone in Adult Congenital Heart Disease
A Phase 2 study testing Spironolactone 25mg in people with Congenital Heart Disease and Heart Failure, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congenital Heart Disease, Heart Failure, Endomyocardial Fibrosis
- What is being tested?
- Spironolactone 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2017
- Phase
- Phase 2
- 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
- Fibrosis index ≥29%, or
- Evidence of cardiovascular dysfunction including any of the following:
- Systemic ejection fraction <55%,
- NYHA 2-3
- 6-minute walk distance <500 m.
- Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease).
- Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.
Who cannot join
- Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
- Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium supplements have been discontinued.
- Moderate/severe systemic atrioventricular valve regurgitation,
- Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
- Unwilling to commit to return visits including mandatory blood draws for potassium,
- Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2),
- Positive urine pregnancy test.
- Any contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo
The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.
Read the detailed description
This study will include randomizing the subject to receive the study drug or placebo. Randomization will occur during visit 1.
Visit 1 will include the following:
- Subjects will answer questions about how well they can breathe.
- An MRI. Dye called gadolinium will be injected into the subject's vein.
- They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
- They will do a 6 minute walk test..
- They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.
Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following:
- They will go to the Oregon Clinical and Translational Research Institute where 1/2 tablespoon of blood will be drawn.
- They will do a 6 minute walk test. During this test, they will walk back and forth in a hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably get out of breath or become exhausted. If they do, they can slow down, stop, or rest as they need to. Blood pressure will be taken before the walk.
- They will have a health review at 6 months.
Visit 6 will be identical to visit 1 and include the following:
- Subjects will answer questions about how well they can breathe.
- An MRI. Dye called gadolinium will be injected into the subject's vein.
- They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
- They will do a 6 minute walk test..
- They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.
The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.
- Being tested
- Spironolactone 25mg, Placebo
- Medical subject headings
- Heart Defects, Congenital, Heart Failure, Endomyocardial Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 25mgDrug
Also called Aldactone 25 mg daily
Spironolactone 25 mg daily for 12 months
PlaceboOther
Placebo daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive placebo Receives: Other: Placebo |
| Spironolactone | Experimental | Spironolactone 25 mg daily Receives: Drug: Spironolactone 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular Volume Fraction
extracellular volume fraction measured by T1 mapping with MRI
Measured: 12 month
Secondary outcomes (2)
6-minute Walk Distance
distance walked recorded in meters after 6 minutes on flat ground
Measured: 12 month
Procollagen 3 NT Peptide
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2016
- Study completionMar 2017
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 Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Clinical and Translational Research Institute
- Responsible party
- Principal investigator, Craig Broberg, Oregon Health and Science University
- Investigators
- Craig Broberg, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069510
- Sponsor's protocol ID
- eIRB 5845
- Other IDs
- K23HL093024-01A1
- Status last verified
- Jul 2019
- First submitted
- 16 Feb 2010
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo
- ClinicalTrials.gov ID
- NCT01069510
- Acronym / sponsor ID
- eIRB 5845
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Clinical and Translational Research Institute
- Study start
- Feb 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.
Detailed description
This study will include randomizing the subject to receive the study drug or placebo. Randomization will occur during visit 1.
Visit 1 will include the following:
- Subjects will answer questions about how well they can breathe.
- An MRI. Dye called gadolinium will be injected into the subject's vein.
- They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
- They will do a 6 minute walk test..
- They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.
Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following:
- They will go to the Oregon Clinical and Translational Research Institute where 1/2 tablespoon of blood will be drawn.
- They will do a 6 minute walk test. During this test, they will walk back and forth in a hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably get out of breath or become exhausted. If they do, they can slow down, stop, or rest as they need to. Blood pressure will be taken before the walk.
- They will have a health review at 6 months.
Visit 6 will be identical to visit 1 and include the following:
- Subjects will answer questions about how well they can breathe.
- An MRI. Dye called gadolinium will be injected into the subject's vein.
- They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
- They will do a 6 minute walk test..
- They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.
The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPatients will receive placebo |
| Spironolactone | Experimental | Drug: Spironolactone 25mgSpironolactone 25 mg daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fibrosis index ≥29%, or
- Evidence of cardiovascular dysfunction including any of the following:
- Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease).
- Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.
Key exclusion criteria (8 listed)
- Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
- Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium supplements have been discontinued.
- Moderate/severe systemic atrioventricular valve regurgitation,
- Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
- Unwilling to commit to return visits including mandatory blood draws for potassium,
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 |
|---|---|---|
| Spironolactone 25mgAlso: Aldactone 25 mg dailySpironolactone 25 mg daily for 12 months | Drug | Spironolactone |
| PlaceboPlacebo daily for 12 months | Other | Placebo |
Primary outcome
Extracellular Volume Fraction
Time frame: 12 month
extracellular volume fraction measured by T1 mapping with MRI
2 secondary outcomes
6-minute Walk Distance
Time frame: 12 month
Procollagen 3 NT Peptide
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Craig Broberg, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone 25mg in people with Congenital Heart Disease and Heart Failure, run by Oregon Health and Science University 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 7 inclusion and 8 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 21 Aug 2019. 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. 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 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.
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 21 Aug 2019). 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?
Extracellular Volume Fraction (time frame: 12 month). 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 21 Aug 2019.