What side effects are associated with this type of intervention?

Common treatments for heart failure include beta-blockers, ACE inhibitors, ARBs, diuretics, and mineralocorticoid receptor antagonists. Beta-blockers can cause fatigue, bradycardia, and hypotension. ACE inhibitors and ARBs may lead to cough, hyperkalemia, and renal impairment. Diuretics often result in electrolyte imbalances, dehydration, and hypotension. Mineralocorticoid receptor antagonists can cause hyperkalemia and renal dysfunction. These side effects should be monitored and managed under the guidance of a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including ACE inhibitors (e.g., enalapril), beta-blockers (e.g., metoprolol), and ARBs (e.g., losartan). More recent approvals include ARNIs like sacubitril/valsartan, which have shown significant benefits in heart failure patients with reduced ejection fraction. Additionally, SGLT2 inhibitors such as dapagliflozin have been approved for heart failure with reduced ejection fraction, demonstrating improvements in cardiovascular outcomes. These treatments align with the patient populations studied in the JK07 trial, which includes heart failure patients with varying ejection fractions.

What other types of research exist?

Promising novel alternatives to JK07 for heart failure patients include ARRY-371797 (PF-07265803), a p38α mitogen-activated protein kinase inhibitor, which has shown improved exercise capacity and reduced natriuretic peptide levels in patients with LMNA-related dilated cardiomyopathy. Additionally, MyoMed-205, a MuRF1 inhibitor, has demonstrated improved myocardial diastolic function and skeletal muscle contractility in HFpEF models. Both therapies are in advanced stages of clinical evaluation and represent potential new options for heart failure treatment in 2024.

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JK07 for Heart Failure (RENEU-HF Trial)

Phase 2

Recruiting

Research Sponsored by Salubris Biotherapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study entry through week 52

Summary

This trial is testing a new medication called JK07 in people aged 18-85 who have heart failure. The study includes two groups based on how well their heart is pumping. Participants will receive either a low dose or high dose of JK07. The goal is to see if JK07 can improve heart function and help these patients feel better.

Who is the study for?

This trial is for adults aged 18-85 with heart failure. It's split into two groups: one with severely reduced pumping function (ejection fraction ≤ 40%) and another with moderately reduced or preserved function (>40% to ≤65%). Participants will be randomly given either a low or high dose of JK07, or a placebo.

What is being tested?

The study tests the safety and effectiveness of different doses of JK07 compared to a placebo in improving heart failure symptoms. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug versus placebo during the trial.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with new heart failure treatments may include changes in blood pressure, kidney function issues, electrolyte imbalances, dizziness, gastrointestinal problems, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study entry through week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study entry through week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and study entry through week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy - Cohort 1

Safety - Cohort 1

Safety - Cohort 2

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: JK07 low doseActive Control1 Intervention

JK07 administered by intravenous (IV) infusion

Group II: JK07 high doseActive Control1 Intervention

JK07 administered by intravenous (IV) infusion

Group III: PlaceboPlacebo Group1 Intervention

Placebo administered by intravenous (IV) infusion

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure (HF) include ACE inhibitors, beta-blockers, diuretics, and investigational therapies like JK07. ACE inhibitors work by blocking the conversion of angiotensin I to angiotensin II, reducing blood pressure and decreasing the heart's workload. Beta-blockers slow the heart rate and reduce blood pressure, improving heart function over time. Diuretics help remove excess fluid from the body, alleviating symptoms like swelling and shortness of breath. Investigational therapies, such as JK07, aim to target specific pathways involved in HF to improve heart function and patient outcomes. These treatments are crucial for managing HF as they help to improve symptoms, enhance quality of life, and reduce the risk of hospitalization and mortality.