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Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study

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Abstract

Background

Left ventricular (LV) remodeling in ischemic cardiomyopathy is the leading cause of heart failure and is an established prognostic factor for adverse cardiovascular events. Experimental studies suggest that sodium tanshinone IIA sulfonate attenuates cardiac remodeling in animal models of acute myocardial infarction (AMI). However, the effects of this drug in the clinical setting remain unclear. Therefore, the STAMP-REMODELING trial is set up to investigate whether treatment with sodium tanshinone IIA sulfonate would prevent the maladaptive progression to adverse LV remodeling in patients following ST-segment elevation myocardial infarction (STEMI).

Methods

Approximately 80 patients with STEMI successfully treated with primary percutaneous coronary intervention (PCI) will be enrolled and randomized to receive sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days) in addition to standard therapy or the same volume of hydration per day. The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with cardiac magnetic resonance imaging (CMR) at baseline and 6 months.

Conclusion

This study will provide important clinical evidence on the efficacy of sodium tanshinone IIA sulfonate treatment in patients with STEMI when used in combination with current therapies that may significantly reduce adverse LV remodeling and potentially improve clinical outcomes.

Trial Registration: Clinical Trials.gov: NCT02524964.

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Abbreviations

ACE:

Angiotensin converting enzyme

AMI:

Acute myocardial infarction

CMR:

Cardiovascular magnetic resonance

EF:

Ejection fraction

LV:

Left ventricular

LVEDV:

Left ventricular end-diastolic volume

LVESV:

Left ventricular end-systolic volume

MACE:

Major adverse cardiac event

MMPs:

Matrix metalloproteinases

NYHA:

New York Heart association functional classification

NSTEACS:

Non-ST elevation acute coronary syndrome

NT-proBNP:

N-terminal pro-brain natriuretic peptide

PCI:

Percutaneous coronary intervention

PMI:

Peri-procedural myocardial injury

SAQ:

Seattle Angina Questionnaire

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Acknowledgments

The authors gratefully acknowledge the contributions of all the investigators, and participants of the trial. This work was financially supported by Postdoctoral Science Foundation of China (No.2015 M570701), Science Foundation of Guangdong Province (No.2015A030310437&2015A030306049) and National Science Foundation of China (No.81473471&81202782&81573708). The sponsors have had no role in the project development, in the collection of data, in the preparation of this manuscript, nor the decision to publish.

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Authors and Affiliations

  1. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China

    Shuai Mao, Lei Wang & Minzhou Zhang

  2. Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China

    Shuai Mao, Lei Wang & Minzhou Zhang

  3. School of Chemistry & Molecular Biosciences, The University of Queensland, Brisbane, 4072, Australia

    Xiaotong Li

  4. Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA

    Phillip C. Yang

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  1. Shuai Mao
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Correspondence to Minzhou Zhang.

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Conflict of Interest

The authors declare that they have no competing interests. None of authors received funding from the relevant drug manufacturers in this research.

Authors’ Contributions

SM and XTL drafted this manuscript; SM, LW and MZZ designed the described study, LW made statistical analysis; PCY made critical revision of the manuscript and contributed to the rationalization of the study. All authors read and approved the final manuscript.

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Mao, S., Li, X., Wang, L. et al. Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study. Cardiovasc Drugs Ther 29, 535–542 (2015). https://doi.org/10.1007/s10557-015-6625-2

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