DRUG
Spironolactone
Spironolactone 12.5mg daily up to a maximum dose of 50 mg daily if tolerated for a total duration of 12 weeks.
Spironolactone Therapy in Chronic Stable Right HF Trial
Status
Completed
Phase
Phase 4
Enrollment
15
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
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
From registration to results.
First posted
Nov 17, 2017
Study start
Apr 1, 2018
Primary completion
Aug 30, 2022
Study completion
May 1, 2024
Results posted
Not reported
Registry updated
May 6, 2026
Outcomes
What the study measures.
Primary outcomes
Change in Ventricular Wall Stress
Time frame · Baseline and 12 weeks
To determine if treatment with spironolactone is associated with a significant reduction in RV ventricular wall stress, as reflected by a reduction in serum NT-proBNP, in patients with chronic stable right HF when compared to placebo.
Secondary outcomes
Change in Cardiac Sympathetic Nervous System Activity
Time frame · Baseline to 12 weeks
Changes in cardiac sympathetic activity, as assessed by an increase in 11\[C\]-hydroxy-ephedrine (HED) retention by cardiac PET imaging.
Change in Cardiac Autonomic Nervous System Function
Time frame · Baseline to 12 weeks
Heart rate variability
Change in Systemic Sympathetic Activation
Time frame · Baseline to 12 weeks
Changes in plasma levels of epinephrine and norepinephrine
Change in Right Ventricle Structure
Time frame · Baseline to 12 weeks
Changes in RV end-diastolic and end-systolic size.
Change in Right Ventricle Function
Time frame · Baseline to 12 weeks
Changes in RV ejection fraction
Change in Right Ventricle areas of fibrosis
Time frame · Baseline to 12 weeks
Changes in RV areas of fibrosis assessed with T1 weighted MR imaging.
Number of participants with treatment-related adverse events.
Time frame · number of adverse events from baseline to 12 weeks.
1\. incidence of worsening renal function (defined as a change in estimated glomerular filtration rate\>30%). 2. Incidence of hyperkalemia (\>4.5, 5 or 5.5 mmol/L)
Change in Biomarkers of Fibrosis
Time frame · Baseline to 12 weeks
Changes in biomarkers of fibrosis (ST2, PIINP, CITB, TIMP1, MMP-9)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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