Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

Conditions

• Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex

ALL

Age

50 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Spironolactone — DRUG
  Treatment with Spironolactone tablets on top of standard care
• Standard care — OTHER
  Standard care does not involve Spironolactone

Study Details

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. SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of CV mortality and HF hospitalization as follows: Population: HFPEF patients in the Swedish Heart Failure Registry and HFPEF patients in US. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF\>=40%. Intervention and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care alone. Outcome: Primary outcome cardiovascular death or time to HF hospitalization. Secondary outcomes include hospitalization for various causes, adverse events and treatment adherence. In Sweden outcomes are obtained automatically by linking with the Population, Patient and Drug Dispensed Registries. In the US, outcomes will be reported by sites and supplemented by data from a call center. The trial is event-driven with enrollment 7 years and study duration 9 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 721 events the sample size requires 1985 patients conservatively rounded to approximately 2000 patients.

Key Dates

Start date

Nov 23, 2017

Status verified

Oct 2024

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

2,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Spironolactone treatment
  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.
• Placebo Comparator: Standard care alone
  Patients in the control arm will get the standard care alone

Primary Outcome Measure

Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death [ Time Frame: Collected at data base lock, five (5) years after study start (US: continuously until 5 years after study start) ]

Central Contacts

• Anna Gustavsson (SWE)
  +46186110181
  [email protected]
• Will Simmons (US)
  919-668-0541
  [email protected]

Locations (38)

Find similar trials in Alexander City, AL

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