Real-world effectiveness and safety of torsemide and spironolactone fixed dose combination in Indian heart failure patients (RESTORE-HF study): a prospective, multicenter, observational study

Background: Heart failure (HF) remains a major public health challenge in India, with a need for effective and well-tolerated therapeutic strategies. Objective: The RESTORE-HF study evaluated the real-world effectiveness and safety of torsemide-spironolactone fixed-dose combination (FDC) in Indian patients with HF. Design: Prospective, multicenter, observational study. Methods: This study was conducted across 101 sites in India. Patients aged 18–75 years with HF with reduced ejection fraction and signs of congestion were enrolled and initiated on the torsemide-spironolactone FDC. Participants were followed over 3 weeks from baseline. The primary objective was the change in body weight. Secondary endpoints included changes in New York Heart Association (NYHA) functional class, edema, occurrence of adverse events (AEs), and physician and patient assessments of efficacy and tolerability. Results: Of the 1841 patients screened, 1752 were enrolled, and 1520 completed the study. The mean (SD) age of participants was 58.61 (9.45) years, of whom 61.05% were male. The study showed a significant reduction in mean body weight was observed from 75.54 kg at baseline to 73.13 kg at week 3 (mean difference: 2.41 kg; p < 0.0001). Additionally, an improvement in NYHA functional class and edema was observed over 3 weeks from baseline. Overall, 22.11% patients achieved no-edema stage. Only three mild AEs related to loose stools were reported, and no serious AEs or deaths occurred. Over 98% of physicians and patients rated the therapy favorably. Conclusion: The RESTORE-HF study demonstrated that the torsemide-spironolactone FDC may be associated with a mean body weight reduction of 2.41 kg and may be generally well-tolerated in Indian heart failure patients. Furthermore, the FDC may be linked to significant symptomatic improvement over 3 weeks in real-world clinical practice.