Mujaj, B. (Blerim)

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    The effect of spironolactone on cardiovascular function and markers of fibrosis in people at increased risk of developing heart failure: the heart 'OMics' in AGEing (HOMAGE) randomized clinical trial
    (Oxford University Press, 2021) Cleland, J.G. (John G.); Ferreira, J.P. (João Pedro); Mariottoni, B. (Beatrice); Pellicori, P. (Pierpaolo); Cuthbert, J. (Joe); Verdonschot, J.A.J. (Job A. J.); Petutschnigg, J. (Johannes); Ahmed, F.Z. (Fozia Z.); Cosmi, F. (Franco); Brunner-La-Rocca, H.P. (Hans-Peter); Mamas, M.A. (Mamas A.); Clark, A.L. (Andrew L.); Edelmann, F. (Frank); Pieske, B. (Burkert); Khan, J. (Javed); McDonald, K. (Ken); Rouet, P. (Philippe); Staessen, J.A. (Jan A.); Mujaj, B. (Blerim); Gonzalez, A. (Arantxa); Diez, J. (Javier); Hazebroek, M.R. (Mark R.); Heymans, S. (Stephane); Latini, R. (Roberto); Grojean, S. (Stéphanie); Pizard, A. (Anne); Girerd, N. (Nicolas); Rossignol, P.(Patrick); Collier, T.J. (Tim); Zannad, F. (Faiez)
    Aims: To investigate the effects of spironolactone on fibrosis and cardiac function in people at increased risk of developing heart failure. Methods and results: Randomized, open-label, blinded-endpoint trial comparing spironolactone (50 mg/day) or control for up to 9 months in people with, or at high risk of, coronary disease and raised plasma B-type natriuretic peptides. The primary endpoint was the interaction between baseline serum galectin-3 and changes in serum procollagen type-III N-terminal pro-peptide (PIIINP) in participants assigned to spironolactone or control. Procollagen type-I C-terminal pro-peptide (PICP) and collagen type-1 C-terminal telopeptide (CITP), reflecting synthesis and degradation of type-I collagen, were also measured. In 527 participants (median age 73 years, 26% women), changes in PIIINP were similar for spironolactone and control [mean difference (mdiff): -0.15; 95% confidence interval (CI) -0.44 to 0.15 μg/L; P = 0.32] but those receiving spironolactone had greater reductions in PICP (mdiff: -8.1; 95% CI -11.9 to -4.3 μg/L; P < 0.0001) and PICP/CITP ratio (mdiff: -2.9; 95% CI -4.3 to -1.5; <0.0001). No interactions with serum galectin were observed. Systolic blood pressure (mdiff: -10; 95% CI -13 to -7 mmHg; P < 0.0001), left atrial volume (mdiff: -1; 95% CI -2 to 0 mL/m2; P = 0.010), and NT-proBNP (mdiff: -57; 95% CI -81 to -33 ng/L; P < 0.0001) were reduced in those assigned spironolactone. Conclusions: Galectin-3 did not identify greater reductions in serum concentrations of collagen biomarkers in response to spironolactone. However, spironolactone may influence type-I collagen metabolism. Whether spironolactone can delay or prevent progression to symptomatic heart failure should be investigated.