Heart failure & cardiomyopathiesRandomised controlled trial
Spironolactone in the Treatment of Heart Failure with Mildly Reduced or Preserved Ejection Fraction: Design and Baseline Characteristics of the SPIRIT-HF-DZHK08 Trial
- Design and baseline characteristics of the SPIRIT-HF randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- phase III
- 1:1 randomisation
- pre-specified individual participant data meta-analysis with TOPCAT Americas
Secondary endpoints (hierarchical): total HF hospitalisations, CV hospitalisations, all hospitalisations, CV death within 24 months · Results first analysed on SPIRIT-HF dataset only, then in a pre-specified individual participant data meta-analysis with TOPCAT Americas
Authors' conclusion
SPIRIT-HF addresses key evidence gaps for spironolactone in high-risk HFpEF/HFmrEF
Study context
- Population
- Patients aged ≥50 years with left ventricular ejection fraction (LVEF) ≥40%, New York Heart Association (NYHA) class II–IV symptoms, and either elevated NT-proBNP or HF hospitalisation within 12 months (HFpEF/HFmrEF)
- Participants
- 730 patients
- Comparison
- Spironolactone vs placebo
- Primary endpoint
- Composite of:
- Rate of total (first and recurrent) HF hospitalisations
- CV death (LWYY model)
- Follow-up
- 24 months from randomisation
Primary result
As reported in the abstract
Baseline characteristics · baseline
- Median age, years
- 77.8
- Women
- 52%
- Median LVEF (50-60)
- 55%
- LVEF 40-49%
- 18%
- Prior HF hospitalisation, SPIRIT-HF vs TOPCAT Americas (similar)
- 46.4% vs. 55%
- NT-proBNP, SPIRIT-HF vs TOPCAT Americas (slightly higher)
- 970 vs. 900 pg/ml
- NYHA class III, SPIRIT-HF vs TOPCAT Americas (similar)
- 33% vs. 35%
- AF at baseline ECG, SPIRIT-HF vs TOPCAT Americas (similar)
- 25% vs. 25%
- CKD, SPIRIT-HF vs TOPCAT Americas (similar)
- 50% vs. 48%
- Beta-blockers, SPIRIT-HF vs TOPCAT Americas (similar)
- 76% vs. 79%
- Diuretics, SPIRIT-HF vs TOPCAT Americas (similar)
- 83% vs. 89%
- Loop diuretics, SPIRIT-HF vs TOPCAT Americas (similar)
- 69% vs. 78%
Original publication
Spironolactone in the Treatment of Heart Failure with Mildly Reduced or Preserved Ejection Fraction: Design and Baseline Characteristics of the SPIRIT-HF-DZHK08 Trial. Eur J Heart Fail. Published 28 July 2026. doi:10.1093/ejhf/xuag222
Summarised from the published abstract; every number is checked against it