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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT02901184
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure with preserved ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but it is generic and will not be studied by industry.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 99
You may be able to join if
- Written informed consent
- Age ≥50 years
- Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
- Left ventricular ejection fraction (LVEF) ≥40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or ≥50% group)
- Elevated natriuretic peptide levels, as defined by any of the following:
You likely can't join if
- Previously enrolled in this study
- Known Ejection Fraction \< 40% ever
- Current absolute indication or contraindication for MRA (mineral receptor antagonist) in judgement of Investigator
- Known chronic liver disease
- Probable alternative explanations for symptoms:
- Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)
See the full eligibility criteria
- Written informed consent
- Age ≥50 years
- Stable heart failure defined by symptoms and signs of heart failure as judged by local Investigator
- Left ventricular ejection fraction (LVEF) ≥40% recorded in last 12 months (stratified to max 2/3rd in either 40-49% or ≥50% group)
- Elevated natriuretic peptide levels, as defined by any of the following:
- most recent NT-proBNP \>300 ng/L (or BNP\>100 pg/mL) in sinus rhythm at time of blood sampling; adjustments may be made for BMI according to table 3.
- most recent NT-proBNP \>750 ng/L (or BNP \>250 pg/mL) in atrial fibrillation at time of blood sampling; adjustments may be made for BMI according to table 3.
- NT-proBNP \>1200 ng/L (or BNP \>400 pg/mL) within the last 12 months even if most recent value is lower.
- Regular use of loop diuretics, defined as daily or most days of the week
- NYHA Class II-IV
- Previously enrolled in this study
- Known Ejection Fraction \< 40% ever
- Current absolute indication or contraindication for MRA (mineral receptor antagonist) in judgement of Investigator
- Known chronic liver disease
- Probable alternative explanations for symptoms:
- Known primary cardiomyopathy (hypertrophic, constrictive, restrictive, infiltrative, congenital)
- Primary hemodynamically significant valve disease
- Right-sided HF not due to left-sided HF
- Significant chronic pulmonary disease defined by Investigator or by requirement for home O2
- Symptomatic anemia, defined as Hemoglobin \< 10 g/dL (100 g/L )
- Heart transplant or LVAD (left ventricular assist device) recipient
- Presence of cardiac resynchronization therapy (CRT) device
- Systolic blood pressure \ 160 mmHg
- K (potassium) \>5.0 mmol/L
- eGFR (estimated glomerular filtration rate) by MDRD (Modification of Diet in Renal Disease) \ 2.5 mg/dL (221 µmol/L )
- Current lithium use
- Current dialysis
- Actual or potential for pregnancy
- Participation in another treatment clinical trial where a mineralocorticoid receptor antagonist is studied
- Any condition that in the opinion of the Investigator may interfere with adherence to trial protocol
The study team makes the final eligibility decision.
Where it's taking place
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Honolulu, Hawaii, United States
- Aurora, Illinois, United States
- Chicago, Illinois, United States
- Elk Grove Village, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Haverhill, Massachusetts, United States
- Natick, Massachusetts, United States
- Newton, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 49 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexander City, Alabama, United States; Birmingham, Alabama, United States; Tucson, Arizona, United States; Washington D.C., District of Columbia, United States; Fort Lauderdale, Florida, United States; Atlanta, Georgia, United States and 63 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.