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CompletedNCT01069510Updated Aug 21, 2019Results posted

Spironolactone in Adult Congenital Heart Disease

A Phase 2 interventional study of Spironolactone 25mg and Placebo in Congenital Heart Disease, Heart Failure and Endomyocardial Fibrosis, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Oregon Health and Science University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Congenital Heart Disease
  • Heart Failure
  • Endomyocardial Fibrosis
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Fibrosis index ≥29%, or

  2. Evidence of cardiovascular dysfunction including any of the following:

    • Systemic ejection fraction \<55%,
    • NYHA 2-3
    • 6-minute walk distance \<500 m.
  3. 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).
  4. Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

Exclusion criteria

Exclusion Criteria:

  1. Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
  2. 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.
  3. Moderate/severe systemic atrioventricular valve regurgitation,
  4. Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
  5. Unwilling to commit to return visits including mandatory blood draws for potassium,
  6. Renal insufficiency (estimated creatinine clearance \< 30 ml/min/1.73m2),
  7. Positive urine pregnancy test.
  8. Any contraindication to MRI.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Patients will receive placebo

    Other: Placebo

  • Experimental
    Spironolactone

    Spironolactone 25 mg daily

    Drug: Spironolactone 25mg

Interventions

  • DrugSpironolactone 25mg

    Spironolactone 25 mg daily for 12 months

    Also known as: Aldactone 25 mg daily

  • OtherPlacebo

    Placebo daily for 12 months

06

What researchers measure

Primary outcomes

  1. Extracellular Volume Fraction

    extracellular volume fraction measured by T1 mapping with MRI

    Time frame: 12 month

Secondary outcomes

  1. 6-minute Walk Distance

    distance walked recorded in meters after 6 minutes on flat ground

    Time frame: 12 month

  2. Procollagen 3 NT Peptide

    Time frame: 12 months

07

Results

Posted Aug 21, 2019

Participant flow

Recruited at time of presentation for larger study. However, most did not meet enrollment criteria and could not be randomized.

Participant flow — Overall Study
MilestonePlaceboSpironolactone
Started87
Completed87
Not completed00

Outcome measures

PrimaryExtracellular Volume Fraction

extracellular volume fraction measured by T1 mapping with MRI

Time frame:
12 month
Reported as:
Mean · percentage of myocardium
Extracellular Volume Fraction
percentage of myocardiumPlaceboSpironolactone
Extracellular Volume Fraction30.1 ± 3.825.3 ± 1.5
Secondary6-minute Walk Distance

distance walked recorded in meters after 6 minutes on flat ground

Time frame:
12 month
Reported as:
Mean · meters
6-minute Walk Distance
metersPlaceboSpironolactone
6-minute Walk Distance516 ± 124492 ± 138
SecondaryProcollagen 3 NT Peptide
Time frame:
12 months
Reported as:
Mean · mcg/l
Procollagen 3 NT Peptide
mcg/lPlaceboSpironolactone
Procollagen 3 NT Peptide3 ± .74.8 ± 1.2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/8 (0%)0/8 (0%)
Spironolactone—0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboSpironolactoneTotal
Mean36 ± 638 ± 1637 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSpironolactoneTotal
Female336
Male549
Region of Enrollment
Region of Enrollment(participants)PlaceboSpironolactoneTotal
United States8715
08

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01069510
Lead sponsor
Oregon Health and Science University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Oregon Clinical and Translational Research Institute
Responsible party
Craig Broberg (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted
Feb 17, 2010
Start date
Feb 2010
Primary completion
Jun 2016
Completion
Mar 2017
Results posted
Aug 21, 2019
Last update
Aug 21, 2019

Study contacts

Craig Broberg, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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