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Spironolactone Therapy in Chronic Stable Right HF Trial — STAR-HF  

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Spironolactone Therapy in Chronic Stable Right HF Trial

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure.

Clinical Trial Description

This study is a phase 4, single center, randomized, double blind, placebo-controlled trial evaluating the safety, tolerability and mechanistic effects of spironolactone, an aldosterone antagonist, on neurohormonal activity and remodeling in patients with chronic right heart failure (RHF). RHF is one of the most important predictors of prognosis in many cardiac disease states including pulmonary hypertension (PH), and left heart failure. Sympathetic nervous system activation plays an important role in the development and progression of heart failure. It remains to be determined whether there is a role for neurohormonal therapy in chronic right HF, but evidence points to the role of sympathetic nervous system stimulation and activation of the renin-angiotensin and aldosterone system as a contributor to progressive right heart failure. The study will determine if treatment with spironolactone is associated with reduction in right ventricular wall stress. In addition, the study aims to evaluate the effects of spironolactone on cardiac sympathetic activity assessed by HED(11 C-hydroxy-ephedrine) retention on PET(positron emission tomography) imaging, and global autonomic function assessed by heart rate variability. Approximately 30 patients with RHF will be randomized to receive either spironolactone daily or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03344159
Study type Interventional
Source Ottawa Heart Institute Research Corporation
Contact
Status Completed
Phase Phase 4
Start date April 1, 2018
Completion date November 30, 2022
View Details
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