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Novel Versus Conventional Sequencing of beta-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

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Background

Chronic heart failure is a serious condition with high rates of illness and death. About half of the patients diagnosed with it die within five years. New treatments like angiotensin receptor-neprilysin inhibitors (ARNIs) and sodium/glucose cotransporter 2 inhibitors (SGLT2is) have shown benefits in reducing death and hospital visits. However, it’s unclear if starting these treatments quickly is better than a slower approach.

Objective

This study aims to find out if starting ARNIs, SGLT2is, β-blockers, and mineralocorticoid receptor antagonists quickly (within 4 weeks) is more effective than starting them slowly (within 6 months) in reducing deaths and hospitalizations for heart failure in patients with stable heart failure and reduced ejection fraction.

Methods

This is a clinical trial where adults with stable heart failure will be divided into two groups: one will receive treatment quickly over 4 weeks, and the other will receive treatment slowly over 6 months. Participants will be monitored for 5 years to evaluate the safety and effectiveness of both approaches.

Results

We are currently working on getting ethical approval and funding for the study.

Conclusions

We hope this study will provide valuable information to improve heart failure treatment guidelines. While we considered including a placebo group, we believe it would be unethical not to provide effective treatments. Funding remains a challenge due to the economic impact of COVID-19.

Measurable Outcomes

Clear goals will be set to evaluate the effectiveness of both treatment approaches in patients with heart failure.

AI Tools for Clinical Needs

We will select AI solutions that are suitable for specific tasks related to the study and patient care.

Implementation

A pilot project will be initiated to track results using AI solutions, focusing on the real-world impact of the study findings.

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