Heart failure (HF) remains a major public health burden in India, highlighting the need to evaluate treatment strategies used in routine clinical care. The RESTORE-HF study published in Therapeutic Advances in Cardiovascular Disease evaluated the real-world effectiveness and safety of a torsemide-spironolactone fixed-dose combination (FDC) in patients with heart failure with reduced ejection fraction (HFrEF) and signs of congestion.

This prospective, multicenter, observational study was conducted across 101 sites in India. Eligible participants were adults aged 18-75 years with HFrEF and clinical evidence of congestion who initiated the FDC and were followed for 3 weeks. Out of 1841 screened individuals, 1752 were enrolled, and 1520 completed the study. The mean (SD) age was 58.61 (9.45) years, and 61.05% were male. 

The primary endpoint, change in body weight, showed a statistically significant reduction from 75.54 kg at baseline to 73.13 kg at week 3 (mean difference: 2.41 kg; p<0.0001). Secondary endpoints demonstrated improvements in New York Heart Association (NYHA) functional class and edema status, with 22.11% reaching a no-edema status. Safety monitoring recorded three mild adverse events (AEs) related to loose stools, with no serious AEs or deaths reported. Physician and patient assessments indicated favorable efficacy and tolerability in over 98% of cases.

These findings suggest short-term improvement in congestion-related measures and functional status among patients receiving the FDC in routine clinical practice. However, longer follow-up and controlled studies are needed to further evaluate these observations.