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American Heart Association

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Final ID: Sa3095

Semiquantitative urine dipstick protein assessments predict clinical outcomes in patients with heart failure and reduced ejection fraction: Insights from the GALACTIC-HF trial

Abstract Body (Do not enter title and authors here):
Background:
Although it is known that increased urinary protein excretion is predictive of both end-stage kidney disease and cardiovascular (CV) outcomes, laboratory quantification of urinary albumin is rarely carried out in CV practice. However, dipstick urine testing is often performed in primary and secondary care, although the results may not be routinely inspected or acted upon. Given the renewed emphasis on CV-metabolic-kidney overlap in medicine, we have examined the prognostic value of semiquantitative urine dipstick protein (DP) assessments in patients with heart failure and reduced ejection fraction (HFrEF).

Hypothesis:
DP predicts clinical outcomes and enables risk stratification in HFrEF.

Methods:
GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a randomized, double-blind, multicenter, event-driven trial that evaluated the efficacy and safety of the cardiac myosin activator omecamtiv mecarbil (OM) versus placebo in 8,232 patients with HFrEF. The primary outcome was a time-to-first-event analysis of a composite of worsening HF (hospitalization or urgent visit) or CV death. We assessed associations between baseline DP and clinical outcomes.

Results:
Baseline DP data were available for 7,790 patients, of whom 5,910 (75.9%) had a negative test or trace proteinuria, 995 (12.8%) had 1+, and 885 (11.4%) had ≥2+ proteinuria. Patients with DP ≥2+ were younger, more often were in NYHA class III/IV and had diabetes, had higher systolic blood pressure, and lower eGFR (Figure). Mean LVEF was 27% across all DP groups.
The rate of the primary outcome (per 100 person-years) increased significantly with increasing DP: negative/trace (21.8, 95% confidential interval [CI] 20.8–22.7); 1+ (34.8, 31.8–38.0); and ≥2+ (38.1, 34.7–41.9). Similar trends were seen for the components of the primary outcome and all cause mortality (Figure). Although individual hazard ratios were partially attenuated after adjustment for recognized prognostic variables, including NT-proBNP and eGFR, higher DP remained significantly associated with worse outcomes.
The treatment effect of OM compared with placebo on clinical outcomes was not modified by DP category.

Conclusions:
DP is a simple inexpensive test with prognostic value in HFrEF.
  • Ono, Ryohei  ( University of Glasgow , Glasgow , United Kingdom )
  • Malik, Fady  ( Cytokinetics , South San Francisco , California , United States )
  • Felker, Gary  ( DUKE CLINICAL RESEARCH INSTITUTE , Durham , North Carolina , United States )
  • Henderson, Alasdair David  ( University of Glasgow , Glasgow , United Kingdom )
  • Jhund, Pardeep  ( University of Glasgow , Glasgow , United Kingdom )
  • Vaduganathan, Muthiah  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Solomon, Scott  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Teerlink, John  ( SAN FRANCISCO VAMC UCSF , San Francisco , California , United States )
  • Mcmurray, John  ( University of Glasgow , Glasgow , United Kingdom )
  • Yang, Mingming  ( University of Glasgow , Glasgow , United Kingdom )
  • Docherty, Kieran  ( University of Glasgow , Glasgow , United Kingdom )
  • Chimura, Misato  ( University of Glasgow , Glasgow , United Kingdom )
  • Metra, Marco  ( University of Brescia , Brescia , Italy )
  • Liu, Genzhou  ( Cytokinetics , South San Francisco , California , United States )
  • Divanji, Punag  ( Cytokinetics , South San Francisco , California , United States )
  • Heitner, Stephen  ( Cytokinetics , South San Francisco , California , United States )
  • Kupfer, Stuart  ( Cytokinetics , South San Francisco , California , United States )
  • Author Disclosures:
    Ryohei Ono: DO NOT have relevant financial relationships | Fady Malik: No Answer | Gary Felker: DO have relevant financial relationships ; Consultant:Novartis:Active (exists now) ; Consultant:Rocket:Active (exists now) ; Research Funding (PI or named investigator):CSL-Behring:Active (exists now) ; Consultant:River2Renal:Active (exists now) ; Research Funding (PI or named investigator):Otsuka:Past (completed) ; Research Funding (PI or named investigator):Novartis:Past (completed) ; Research Funding (PI or named investigator):Bayer:Active (exists now) ; Research Funding (PI or named investigator):Cyotkinetics:Active (exists now) ; Consultant:Roche Diagnostics:Past (completed) ; Consultant:Boehringer Ingelheim:Active (exists now) ; Consultant:Cytokinetics:Active (exists now) ; Consultant:Merck:Active (exists now) ; Consultant:BMS:Active (exists now) | Alasdair Henderson: DO have relevant financial relationships ; Consultant:Bayer:Active (exists now) | Pardeep Jhund: DO have relevant financial relationships ; Consultant:AstraZeneca:Active (exists now) ; Other (please indicate in the box next to the company name):Director GCTP :Active (exists now) ; Researcher:Analog Devices :Active (exists now) ; Researcher:Roche Diagnostics:Active (exists now) ; Researcher:AstraZeneca:Past (completed) ; Researcher:Boheringer Ingelheim:Past (completed) ; Consultant:Bayer:Active (exists now) | Muthiah Vaduganathan: DO have relevant financial relationships ; Consultant:American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, Cytokinetics, Esperion, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi and Tricog Health:Active (exists now) ; Research Funding (PI or named investigator):Amgen, AstraZeneca, Boehringer Ingelheim, Galmed, Novartis, Bayer AG, Occlutech, Pharmacosmos, and Impulse Dynamics:Active (exists now) | Scott Solomon: DO have relevant financial relationships ; Research Funding (PI or named investigator):Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos/BridgeBio, Gossamer, GSK, Ionis, Lilly,NIH/NHLBI, Novartis, NovoNordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, US2.AI:Active (exists now) ; Consultant:Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, Askbio, AstraZeneca, Bayer, BMS, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Intellia, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, Valo, Synhale, Recordati:Active (exists now) | John Teerlink: DO have relevant financial relationships ; Consultant:Amgen:Active (exists now) ; Consultant:LivaNova:Past (completed) ; Consultant:Kaiser Permanente:Active (exists now) ; Consultant:Impulse Dynamics:Active (exists now) ; Consultant:Endotronix:Active (exists now) ; Consultant:Edwards:Active (exists now) ; Consultant:EBR Systems, Inc. :Active (exists now) ; Consultant:Cytokinetics:Active (exists now) ; Consultant:Cardurion:Active (exists now) ; Consultant:Bristol-Myers Squibb:Active (exists now) ; Consultant:Boehringer-Ingelheim:Active (exists now) ; Consultant:Bayer:Active (exists now) ; Consultant:AstraZeneca:Active (exists now) ; Consultant:AskBio:Active (exists now) ; Consultant:Angitia:Active (exists now) | John McMurray: DO NOT have relevant financial relationships | Mingming Yang: DO NOT have relevant financial relationships | Kieran Docherty: DO have relevant financial relationships ; Consultant:Us2.Ai:Past (completed) ; Researcher:Fire1:Active (exists now) ; Researcher:Bayer:Active (exists now) ; Researcher:Cytokinetics:Active (exists now) ; Researcher:AstraZeneca:Active (exists now) ; Research Funding (PI or named investigator):Roche diagnostics:Active (exists now) ; Research Funding (PI or named investigator):Boehringer Ingelheim:Active (exists now) ; Speaker:Pharmacosmos:Past (completed) ; Speaker:AstraZeneca:Past (completed) | Misato Chimura: DO NOT have relevant financial relationships | Marco Metra: DO have relevant financial relationships ; Advisor:Astra-Zeneca:Past (completed) ; Speaker:Boehringer Ingelheim:Past (completed) ; Advisor:Roche Diagnostics:Past (completed) ; Advisor:NovoNordisk:Past (completed) ; Advisor:Boehringer Ingelheim:Past (completed) ; Advisor:Bayer:Past (completed) | Genzhou Liu: DO NOT have relevant financial relationships | Punag Divanji: No Answer | Stephen Heitner: DO have relevant financial relationships ; Employee:Cytokinetics Inc.:Active (exists now) ; Individual Stocks/Stock Options:Cytokinetics Inc.:Active (exists now) | Stuart Kupfer: DO have relevant financial relationships ; Employee:Cytokinetics:Active (exists now) ; Individual Stocks/Stock Options:Cytokinetics:Active (exists now)
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Biomarkers in HF: Past, Present, and Future

Saturday, 11/08/2025 , 02:30PM - 03:30PM

Abstract Poster Board Session

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