What side effects are associated with this type of intervention?

Common treatments for heart failure include beta-blockers, ACE inhibitors, ARBs, diuretics, and SGLT2 inhibitors. Beta-blockers can cause fatigue, bradycardia, and hypotension. ACE inhibitors and ARBs may lead to cough, hyperkalemia, and renal dysfunction. Diuretics often result in electrolyte imbalances and dehydration. SGLT2 inhibitors are associated with urinary tract infections and genital infections. These side effects are important to consider when evaluating new treatments like XXB750.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including beta-blockers (e.g., metoprolol, carvedilol), ACE inhibitors (e.g., enalapril, lisinopril), ARBs (e.g., losartan, valsartan), and aldosterone antagonists (e.g., spironolactone, eplerenone). More recently, SGLT2 inhibitors like dapagliflozin and empagliflozin have been approved for heart failure with reduced ejection fraction. These treatments aim to improve symptoms, reduce hospitalizations, and increase survival rates in heart failure patients.

What other types of research exist?

Promising novel alternatives for heart failure treatment in 2024 include: 1) SGLT2 inhibitors like dapagliflozin and empagliflozin, which have shown benefits in heart failure with reduced ejection fraction (HFrEF) and mildly reduced ejection fraction (HFmrEF). 2) Vericiguat, a soluble guanylate cyclase stimulator, approved for reducing the risk of cardiovascular death and heart failure hospitalization. 3) Omecamtiv mecarbil, a cardiac myosin activator, which improves cardiac contractility. 4) Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, which has demonstrated significant benefits in heart failure patients.

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Unknown

XXB750 for Heart Failure

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

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 91 days (cohort 1), 146 days (cohort 2)

Summary

This trial tests a new medication, XXB750, in patients with certain types of heart failure. It aims to see if the drug can improve heart function and be safely used alongside other treatments.

Who is the study for?

This trial is for adults with heart failure who have a left ventricular ejection fraction (LVEF) of 50% or less. They must have stable blood pressure and heart rate, be on certain heart medications, and not severely overweight. Excluded are those with severe lung disease, recent acute heart failure or cardiovascular events, significant valve disease, recent device implantation in the heart, or poor kidney function.

What is being tested?

The study tests the safety and tolerability of a new medication called XXB750 compared to a placebo in patients with reduced (HFrEF) or mildly reduced (HFmrEF) ejection fraction. Participants will receive either XXB750 or placebo without knowing which one they get while researchers monitor their reactions over time.

What are the potential side effects?

While specific side effects of XXB750 aren't listed here, common side effects for drugs treating heart failure may include dizziness due to low blood pressure, changes in heartbeat rhythm, kidney problems, swelling due to fluid retention and fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 91 days (cohort 1), 146 days (cohort 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~91 days (cohort 1), 146 days (cohort 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 91 days (cohort 1), 146 days (cohort 2) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events, which may include abnormal vital signs, safety lab tests, or ECG parameters that induce clinical signs or symptoms, are considered clinically significant or require therapy

Secondary study objectives

Pharmacokinetics parameters AUCinf for Cohort 1

Pharmacokinetics parameters AUClast for Cohort 1

Pharmacokinetics parameters AUCtau for Cohort 2

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: XXB750 Cohort 2Experimental Treatment1 Intervention

XXB750, multiple doses

Group II: XXB750 Cohort 1Experimental Treatment1 Intervention

XXB750, single dose

Group III: Placebo Cohort 1Placebo Group1 Intervention

Placebo, single dose

Group IV: Placebo Cohort 2Placebo Group1 Intervention

Placebo, multiple doses

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XXB750

2022

Completed Phase 1

~110

Do I qualify?Apply below to find out

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) work through various mechanisms to improve heart function and patient outcomes. ACE inhibitors and angiotensin receptor blockers (ARBs) reduce the workload on the heart by dilating blood vessels, thereby lowering blood pressure and decreasing fluid retention. Beta-blockers slow the heart rate and reduce blood pressure, which helps to improve heart function and reduce symptoms. Diuretics help to remove excess fluid from the body, reducing the burden on the heart. Aldosterone antagonists prevent fluid retention and reduce fibrosis in the heart. Device therapies like CRT improve the coordination of heart muscle contractions, and ICDs prevent sudden cardiac death by correcting life-threatening arrhythmias. These treatments are crucial for HF patients as they help to manage symptoms, improve quality of life, and reduce the risk of hospitalization and mortality.

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