Effect of Losartan on Right Ventricular Dysfunction: Results From the Double-Blind, Randomized REDEFINE Trial (Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-Angiotensin-Aldosterone System) in Adults With Repaired Tetralogy of Fallot
Primary result · RV EFResult — go to the resultDifference +0.51 % 95% CI −1.0 to +2.0Authors' conclusion
Losartan had no significant effect on RV dysfunction or secondary outcome parameters in repaired tetralogy of Fallot.
Study context
- Population
- Adults with repaired tetralogy of Fallot and right ventricular (RV) dysfunction (RV EF <50%) without severe valvular dysfunction
- Participants
- 95 adults
- Comparison
- Losartan vs placebo
- Losartann = 47
- Placebon = 48reference
- Primary endpoint
- RV EF change by cardiovascular MRI
Methodological detailsinvestigator-initiated, multicentre, prospective, double-blind, placebo-controlled
- Investigator-initiated
- Multicentre
- Prospective
- Double-blind
- Placebo-controlled
Primary result
RV EF
Difference
+0.51 %
95% CI −1.0 to +2.0
P = 0.50
By group
As reported in the abstract
Secondary outcomes
| Outcome | Difference (%) (95% CI) | P value |
|---|---|---|
| RV EF in subgroup with nonrestrictive RV and incomplete remodeling (post hoc, n=30)Post hoc analysis | +2.7 (+0.1 to +5.4) | P = 0.045 |
LV EF, peak aerobic exercise capacity, NT-proBNP
- No significant treatment effects
- P > 0.30 for all
RV EF in predefined subgroups (symptoms, restrictive RV, RV EF<40%, pulmonary valve replacement, QRS fragmentation)
- No statistically significant impact of losartan
Original publication
Effect of Losartan on Right Ventricular Dysfunction: Results From the Double-Blind, Randomized REDEFINE Trial (Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-Angiotensin-Aldosterone System) in Adults With Repaired Tetralogy of Fallot. Circulation. Published 8 December 2017. doi:10.
Summarised from the published abstract; every number is checked against it