Spironolactone treatment for Heart Failure

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Heart Failure+1 More
Spironolactone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start)

Collected at data base lock, five (5) years after study start
Perinatal death
Year 5
Incidence rate for all-cause hospitalizations
Incidence rate for all-cause hospitalizations or all-cause mortality
Incidence rate for total HF hospitalizations
Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
Time to CV Death
Time to CV Death or first HF hospitalization
Time to HF hospitalizations
Time to all-cause hospitalizations

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Spironolactone treatment
1 of 2
Standard care alone
1 of 2

Active Control

Non-Treatment Group

3200 Total Participants · 2 Treatment Groups

Primary Treatment: Spironolactone treatment · Has Placebo Group · Phase 3

Standard care alone
Other
PlaceboComparator Group · 1 Intervention: Standard care · Intervention Types: Other
Spironolactone treatment
Drug
ActiveComparator Group · 1 Intervention: Spironolactone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: collected at data base lock, five (5) years after study start (us: continuously until 5 years after study start)

Who is running the clinical trial?

Uppsala UniversityLead Sponsor
416 Previous Clinical Trials
2,546,749 Total Patients Enrolled
6 Trials studying Heart Failure
10,350 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,577 Previous Clinical Trials
46,965,390 Total Patients Enrolled
193 Trials studying Heart Failure
674,327 Patients Enrolled for Heart Failure
Duke Clinical Research InstituteOTHER
57 Previous Clinical Trials
228,117 Total Patients Enrolled
7 Trials studying Heart Failure
15,143 Patients Enrolled for Heart Failure
Karolinska UniversityOTHER
2 Previous Clinical Trials
5,015 Total Patients Enrolled
Bertram PittPrincipal InvestigatorUniversity of Michigan
Lars H Lund, MD, PhDPrincipal InvestigatorKarolinska Institutet

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have heart failure with a left ventricular ejection fraction (LVEF) ≥40% in the last 12 months.
You have been diagnosed with heart failure within the last 12 months.
You use a loop diuretic daily or most days of the week.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.