Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial.
Abstract | AIMS: METHODS AND RESULTS: The HOMAGE trial is a prospective, randomised, open-label, blinded endpoint (PROBE) study comparing spironolactone (up to 50 mg/day) and standard care over 9 months in people with clinical risk factors for developing HF, including hypertension, CAD and T2DM, and elevated plasma concentrations of N-terminal pro- B-type natriuretic peptide ( NT-proBNP, 125 to 1000 ng/L) or B-type natriuretic peptide (BNP, 35 to 280 ng/L). Exclusion criteria included left ventricular ejection fraction < 45%, atrial fibrillation, severe renal dysfunction, or treatment with loop diuretics. The primary endpoint was the interaction between change in serum concentrations of procollagen type III N-terminal propeptide ( PIIINP) and treatment with spironolactone according to median plasma concentrations of galectin-3 at baseline. For the 527 participants enrolled, median (interquartile range) age was 73 (69-79) years, 135 (26%) were women, 412 (78%) had hypertension, 377 (72%) CAD, and 212 (40%) T2DM. At baseline, medians (interquartile ranges) were for left ventricular ejection fraction 63 (58-67) %, for left atrial volume index 31 (26-37) mL/m2 , for plasma NT-proBNP 214 (137-356) ng/L, for serum PIIINP 3.9 (3.1-5.0) ng/mL, and for galectin-3 16.1 (13.5-19.7) ng/mL. CONCLUSIONS: The HOMAGE trial will provide insights on the effect of spironolactone on pathways that might drive progression to HF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02556450.
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Authors | Pierpaolo Pellicori, João Pedro Ferreira, Beatrice Mariottoni, Hans-Peter Brunner-La Rocca, Fozia Z Ahmed, Job Verdonschot, Tim Collier, Joe J Cuthbert, Johannes Petutschnigg, Blerim Mujaj, Nicolas Girerd, Arantxa González, Andrew L Clark, Franco Cosmi, Jan A Staessen, Stephane Heymans, Roberto Latini, Patrick Rossignol, Faiez Zannad, John G F Cleland |
Journal | European journal of heart failure
(Eur J Heart Fail)
Vol. 22
Issue 9
Pg. 1711-1723
(09 2020)
ISSN: 1879-0844 [Electronic] England |
PMID | 31950604
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2020 European Society of Cardiology. |
Chemical References |
- Biomarkers
- Peptide Fragments
- Natriuretic Peptide, Brain
- Spironolactone
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Topics |
- Aged
- Aging
- Biomarkers
- Diabetes Mellitus, Type 2
- Female
- Fibrosis
- Heart Failure
(drug therapy, prevention & control)
- Humans
- Male
- Natriuretic Peptide, Brain
- Peptide Fragments
- Prospective Studies
- Spironolactone
- Stroke Volume
- Ventricular Function, Left
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