Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system (REDEFINE) trial: Rationale and design of a randomized, double-blind, placebo-controlled clinical trial - 16/05/17

Doi : 10.1016/j.ahj.2016.12.014

Jouke P. Bokma, MD ^a,^b, Michiel M. Winter, MD, PhD ^a, Esmée M. Kornaat, BSc ^a, Hubert W. Vliegen, MD, PhD ^c, Arie P. van Dijk, MD, PhD ^d, Joost P. van Melle, MD, PhD ^e, Folkert J. Meijboom, MD, PhD ^f, Martijn C. Post, MD, PhD ^g, Jacqueline K. Berbee, MSc ^h, Aeilko H. Zwinderman, PhD ⁱ, Barbara J.M. Mulder, MD, PhD ^a,^b, Berto J. Bouma, MD, PhD ^a,^b,^{^⁎}
^a Department of Cardiology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands
^b Interuniversity Cardiology Institute of the Netherlands, Utretch, the Netherlands
^c Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
^d Department of Cardiology, Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands
^e Department of Cardiology, University of Groningen, Groningen University Medical Center, Groningen, the Netherlands
^f Department of Cardiology, Utrecht University Medical Center, Utrecht, the Netherlands
^g Department of Cardiology, Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands
^h Department of Hospital Pharmacy, Academic Medical Center Amsterdam, Amsterdam, the Netherlands
ⁱ Department of Clinical Epidemiology and Biostatistics, Academic Medical Center Amsterdam, Amsterdam, the Netherlands

^⁎Reprint requests: Berto J. Bouma, MD, PhD, Department of Cardiology, Academic Medical Center Amsterdam, Room B2-256, Meibergdreef 9, Amsterdam 1105 AZ, the Netherlands.Department of CardiologyAcademic Medical Center AmsterdamRoom B2-256, Meibergdreef 9Amsterdam1105 AZthe Netherlands

Background

Renin-angiotensin-aldosterone system (RAAS) inhibition with angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors is beneficial in patients with acquired left ventricular dysfunction. Adult patients with tetralogy of Fallot (TOF) with right ventricular (RV) dysfunction are at high risk for heart failure, arrhythmias, and sudden cardiac death. However, the efficacy of RAAS inhibition has not been established in these patients.

Methods

The REDEFINE is an investigator-initiated, multicenter, prospective, randomized, double-blind, placebo-controlled trial to study the effects of the angiotensin II receptor blocker losartan (target dosage of 150 mg once daily) in adult patients with TOF. Patients with RV dysfunction in the absence of severe valvular dysfunction are eligible for inclusion. The primary end point is the change in RV ejection fraction after 18 to 24 months, as measured by cardiovascular magnetic resonance imaging. In addition, laboratory measurements, echocardiography, and cardiopulmonary exercise testing are performed.

Conclusion

The REDEFINE trial will study the effects of RAAS inhibition with losartan in TOF patients with RV dysfunction.

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Plan

Cardiovascular magnetic resonance

Sample size and statistical considerations

Data and Safety Monitoring Board

Study participants

Intraobserver agreement

Discussion

Limitations

Summary

	Funding sources: This work was supported by the Netherlands Heart Institute, Nuts Ohra Foundation, and Stichting Dalijn. The work described in this study was carried out in the context of the Parelsnoer Institute. Parelsnoer Institute is part of and funded by the Dutch Federation of University Medical Centers.
	Conflicts of interest: None.
	RCT No. NCT02010905

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Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system (REDEFINE) trial: Rationale and design of a randomized, double-blind, placebo-controlled clinical trial - 16/05/17

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