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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

Must not have

Current lithium use

Current dialysis

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

Approved for 10 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking lithium.

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I am currently on dialysis.

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My kidney function is severely reduced.

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I am not in a study testing a mineralocorticoid receptor blocker.

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I have a long-term liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at data base lock, five (5) years after study start (us: continuously until 5 years after study start)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death

Secondary study objectives

Incidence rate for all-cause hospitalizations

Incidence rate for all-cause hospitalizations or all-cause mortality

Incidence rate for total HF hospitalizations

+5 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 8Eligibility criteria met