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Mineralocorticoid Receptor Antagonist

Spironolactone for Heart Failure (SPIRRIT Trial)

Phase 3
Recruiting
Led By Lars H Lund, MD, PhD
Research Sponsored by Uppsala University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Regular use of loop diuretics, defined as daily or most days of the week
NYHA Class II-IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at data base lock, five (5) years after study start (us: continuously until 5 years after study start)
Awards & highlights

SPIRRIT Trial Summary

This trial will test if spironolactone, a generic drug, can help people with HFPEF, a common but deadly condition.

Who is the study for?
This trial is for people over 50 with heart failure where the heart still pumps well (LVEF ≥40%), experiencing symptoms most days, and on diuretics. They must have high levels of a specific heart stress marker in their blood. It's not for those with severe kidney issues, on dialysis, pregnant or might become so, using lithium, or if they've had a very weak heart pump (<40%) before.Check my eligibility
What is being tested?
The SPIRRIT study is checking if adding spironolactone to usual care helps patients with HFPEF better than usual care alone by reducing death from cardiovascular causes or hospital stays due to heart failure. Participants are randomly chosen to receive either spironolactone plus standard treatment or just standard treatment.See study design
What are the potential side effects?
Spironolactone can cause changes in electrolyte levels like high potassium which can be dangerous for the heart, kidney problems, low blood pressure, dizziness and could potentially worsen liver conditions.

SPIRRIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I regularly take water pills for my condition.
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I have moderate to severe heart condition symptoms.
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I am 50 years old or older.

SPIRRIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at data base lock, five (5) years after study start (us: continuously until 5 years after study start)
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at data base lock, five (5) years after study start (us: continuously until 5 years after study start) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
Secondary outcome measures
Incidence rate for all-cause hospitalizations
Incidence rate for all-cause hospitalizations or all-cause mortality
Incidence rate for total HF hospitalizations
+5 more

SPIRRIT Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Spironolactone treatmentActive Control1 Intervention
Spironolactone will be prescribed by the Investigator and filled by patient at conventional pharmacies as 25 mg tablets. The treatment will be on top of standard care. Initial dose is 25 mg/day, which will be increased to target dose 50 mg/day if tolerated. Eplerenone can be prescribed if spironolactone is not tolerated.
Group II: Standard care alonePlacebo Group1 Intervention
Patients in the control arm will get the standard care alone

Find a Location

Who is running the clinical trial?

Uppsala UniversityLead Sponsor
484 Previous Clinical Trials
2,914,223 Total Patients Enrolled
7 Trials studying Heart Failure
11,878 Patients Enrolled for Heart Failure
Karolinska UniversityOTHER
2 Previous Clinical Trials
5,015 Total Patients Enrolled
Duke Clinical Research InstituteOTHER
63 Previous Clinical Trials
239,532 Total Patients Enrolled
7 Trials studying Heart Failure
15,140 Patients Enrolled for Heart Failure

Media Library

Spironolactone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02901184 — Phase 3
Heart Failure Research Study Groups: Spironolactone treatment, Standard care alone
Heart Failure Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT02901184 — Phase 3
Spironolactone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02901184 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Spironolactone for therapeutic use?

"Spironolactone treatment scores a 3 in terms of safety. This is due to the fact that Phase 3 trials have shown both efficacy and safety in multiple rounds of testing."

Answered by AI

Are we currently looking for volunteers for this experiment?

"The clinicaltrials.gov website contains information revealing that this trial is recruiting patients. This trial was originally posted on 11/23/2017 and was last edited on 8/23/2022. The study is looking for 3200 patients across 38 locations."

Answered by AI

What is the uppermost patient limit for this experiment?

"Yes, the study is still recruiting patients. The information was last updated on 8/23/2022 and originally posted on 11/23/2017. There are 38 locations recruiting a total of 3200 patients."

Answered by AI

What have been some success stories of Spironolactone treatments?

"Spironolactone is a medication prescribed to patients with primary hyperaldosteronism. However, Spironolactone is also an effective medication for other conditions such as cirrhosis of the liver and acne."

Answered by AI

Are there any other existing studies that observe the effects of Spironolactone?

"Spironolactone was first studied in 2013 at Brigham and Women's Hospital. To date, there have been 207 completed clinical trials with 29 more currently recruiting patients. The majority of these active trials are based in Pittsburgh, Pennsylvania."

Answered by AI

Who would be an ideal candidate to enroll in this clinical research?

"This study is looking for 3200 patients with heart failure between the ages of 50 and 99. Most importantly, candidates must meet the following 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), most recent NT-proBNP >300 ng/L (or BNP>100 pg/mL) in sinus rhythm at time of blood sampling;"

Answered by AI

Can patients who are over 55 years old participate in this clinical trial?

"This study includes a age range from 50 to 99 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
2017. "Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02901184.
~574 spots leftby Dec 2026
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