Key result
Spironolactone fails to improve 6MWD over standard treatment in idiopathic PAH.
Why the study?
Despite aldosterone's role in pulmonary arterial hypertension pathophysiology, few clinical reports describe the effect of aldosterone antagonist therapy in this population.
Does spironolactone added to standard therapy improve 6-minute walk distance and right ventricular function in patients with idiopathic pulmonary arterial hypertension?
RCT (n=45)
Double-blind
PASS randomization software
No
Does spironolactone added to standard therapy improve 6-minute walk distance and right ventricular function in patients with idiopathic pulmonary arterial hypertension?
The addition of spironolactone to standard therapy in patients with idiopathic pulmonary arterial hypertension significantly affected TAPSE but did not improve 6-minute walk distance or other echocardiographic parameters over 3 months.
No benefit on 6MWD cautions against routine spironolactone addition in idiopathic PAH; extends negative evidence on functional endpoints.
ObjectivesDespite the evidence showing the effect of vasoactive hormones including aldosterone in the pathophysiology of pulmonary arterial hypertension (PAH), few clinical reports are available about the effect of treating PAH with aldosterone antagonists, so in this study, the effect of treating patients with idiopathic PAH with the drug Aldosterone inhibitor spironolactone was discussed. MethodologyThis study was conducted as a randomized clinical trial with a double-blind control group.All patients diagnosed with PAH referred to Imam Reza (AS) hospital in Mashhad from the beginning of August 2015 to the beginning of August 2016 were included in this study.The patients were randomly treated with the standard treatment of tadalafil 10-20 mg once a day plus bozentan 125 mg, once or twice a day or standard treatment plus spironolactone (25 mg) daily for three months.Before the start and after three months, the patients were evaluated.After collecting the data, they were analyzed using SPSS version 16 software, and p>0.05 was considered as a significant level. ResultsRoutine treatment in the control group and routine treatment plus spironolactone in the intervention group had little effect on the severity of dilatation of the patients participating in the study but it had significant effect on TAPSE. ConclusionAfter the intervention a significant increase in the TAPSE index was observed compared to the control group.Significant difference in other echocardiographic and clinical indicators examined after the intervention in the intervention groups and the witness was not identified.
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yeganeh (2023) conducted an RCT in Idiopathic Pulmonary Arterial Hypertension (PAH) (n=45). Spironolactone vs. Standard treatment (tadalafil 10-20 mg daily plus bosentan 125 mg once or twice daily) was evaluated on 6-minute walk distance (6MWD) (p=0.235). Spironolactone added to standard treatment did not significantly improve the 6-minute walk distance compared to standard treatment alone in patients with idiopathic pulmonary arterial hypertension.
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