Spironolactone Therapy in Chronic Stable Right HF Trial (STAR-HF)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    30
  • sponsor
    Ottawa Heart Institute Research Corporation
Updated on 3 March 2022
hypertension
diuretics
spironolactone
cardiac mri
right ventricular failure
tapse

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.

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.

Details
Condition Chronic Right-Sided Heart Failure, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Primary, 2, Pulmonary Hypertension, Primary, 3, Pulmonary Hypertension, Primary, 4, Cardiomyopathy Right Ventricular
Treatment Placebo, Spironolactone, PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82, Cardiac MRI (Gadolinium enhanced)
Clinical Study IdentifierNCT03344159
SponsorOttawa Heart Institute Research Corporation
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide a personally signed and dated inform consent form
Male or female 18 years
Able to comply with all study procedures
History of right heart failure (RHF) secondary to either: i) WHO, group 1 pulmonary arterial hypertension PAH OR ii) WHO group II PH with normal LV systolic function OR iii) WHO group III or IV PH OR iv) primary RV cardiomyopathy
Current NYHA II-IV
RV dysfunction as measured by 2D echocardiogram
i)defined as a tricuspid annular plane systolic excursion (TAPSE) <16 mm ii)
and /or a two dimensional fractional area change <35% on screening echo plus
NT-proBNP>400 pg/ml
Chronic use of diuretics
Clinical stability: defined as no need for increased diuretics, hospitalization or emergency room visit 3 months prior to enrollment

Exclusion Criteria

Patients on chronic MRA therapy or other potassium sparing diuretics
Baseline serum potassium>5 ummol/l
Estimated glomerular filtration rate <30 ml/min
LV ejection fraction <45%
Moderate or severe LV diastolic function
Moderate or severe aortic or valvular disease
Patients requiring augmentation of diuretics or otherwise not meeting definition for clinical stability
Severe Liver Failure (Child-Pugh Class C)
Claustrophobia or inability lie still in a supine position
Patients with contraindications to either PET or CMR imaging
Pregnancy or lactation
Unable to provide consent and comply with follow up visits
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