NCT03344159

Spironolactone Therapy in Chronic Stable Right HF Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Right-Sided Heart Failure
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension, Primary, 2
• Pulmonary Hypertension, Primary, 3
• Pulmonary Hypertension, Primary, 4
• Cardiomyopathy Right Ventricular

Interventions

Type	Name	Description
DRUG	Spironolactone	Spironolactone 12.5mg daily up to a maximum dose of 50 mg daily if tolerated for a total duration of 12 weeks.
DRUG	Placebo	Placebo daily for a total of duration of 12 weeks
RADIATION	PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82	At baseline and 12 weeks, all participants will undergo rest perfusion PET imaging according to standard protocols with either 82-Rb or N-13 NH3, followed by C-11 HED PET.
DIAGNOSTIC_TEST	Cardiac MRI (Gadolinium enhanced)	At baseline and 12 weeks all participants will undergo cMR to assess RV function and structure. We will acquire precontrast T2 and native T1 maps, and post gadolinium T1 maps.

Timeline

• Start date: 2018-04-01
• Primary completion: 2022-08-30
• Completion: 2024-05-01
• First posted: 2017-11-17
• Last updated: 2024-07-01

Locations

1 site across 1 country: Canada