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Novel Versus Conventional Sequencing of β-Blockers, Sodium/Glucose Cotransportor 2 Inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, and Mineralocorticoid Receptor Antagonists in Stable Patients With Heart Failure With Reduced Ejection Fraction (NovCon Sequencing Study): Protocol for a Randomized Controlled Trial
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Novel versus Conventional sequencing of Beta-blockers, SGLT2i’s, ARNI’s and MRAs in stable patients with HFrEF (NovCon sequencing study): protocol for a 5-year pragmatic, real world, open label, randomised clinical trial
Sumanth Karamchand;
Tsungai Chipamaunga;
Poobalan Naidoo;
Kiolan Naidoo;
Virendra Rambiritch;
Kevin Ho;
Robert Chilton;
Kyle McMahon;
Rory Leisegang;
Hellmuth Weich;
Karim Hassan
ABSTRACT
Background:
Chronic heart failure has a high morbidity and mortality, with approximately half of patients demising within 5 years of diagnosis. Recent additions to the armamentarium of anti-heart failure therapies include the angiotensin receptor-neprylisin inhibitors (ARNIs) and sodium/glucose co-transmitter 2 inhibitors (SGLT2i). Both classes have demonstrated mortality and morbidity benefits.
Objective:
To determine if early addition of ARNIs, SGLT2i’s, beta blockers and mineralocorticoid receptor antagonists) (within 4 weeks) will reduce all-cause mortality and hospitalisations for heart failure in patients with stable heart failure with reduced ejection fraction.
Methods:
This is a single center, randomised, controlled, double arm, open label, active control, pragmatic clinical trial. Adults with stable heart failure with reduced ejection fraction and idiopathic dilated cardiomyopathy will be randomised to conventional sequencing (the control arm) (over 6 months) of anti-failure therapies and a second arm will receive rapid sequencing (over 4 weeks). Study participants will be followed for 5 years to assess safety, efficacy and tolerability of the two types of sequencing. Post-trial access and care will be provided to all study participants throughout their lifespan.
Results:
We are currently in the process of obtaining ethical clearance and funding.
Conclusions:
We envisage that the current study will help inform clinical practice guidelines on the optimal sequencing of anti-heart failure therapies.
Novel Versus Conventional Sequencing of β-Blockers, Sodium/Glucose Cotransportor 2 Inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, and Mineralocorticoid Receptor Antagonists in Stable Patients With Heart Failure With Reduced Ejection Fraction (NovCon Sequencing Study): Protocol for a Randomized Controlled Trial