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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)
Awards & highlights
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)
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 moreTrial 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
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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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,977 Total Patients Enrolled
68 Trials studying Heart Failure
2,001,687 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of serious lung disease needing ongoing oxygen therapy or medicine for high blood pressure in the lungs.Your heart's pumping ability is less than 50% as shown in recent tests.Your blood pressure is between 110-160 mmHg for cohort 1 or 105-160 mmHg for cohort 2, and your heart rate is between 50-90 beats per minute.You have heart problems that affect your ability to do regular activities.You had severe heart failure in the last 3 months before the screening.You are currently taking a steady amount of sacubitril/valsartan.You have had a heart attack, stroke, or major heart or blood vessel surgery in the past 6 months.You have a serious problem with your heart valves, except for a specific type of problem with the mitral valve.You had a CRT device implanted within the last 3 months or plan to get one during the study.Your kidney function is less than 45 mL/min/1.73 m2.You are currently taking or have taken sacubitril/valsartan within the past 4 weeks.If you are taking a stable dose of ACE inhibitor or ARB, you can participate in Cohort 1.You are currently taking or have taken ACE inhibitors or ARB within the past 4 weeks.You have a very high body mass index (BMI).You are currently taking a consistent amount of a beta blocker.
Research Study Groups:
This trial has the following groups:- Group 1: XXB750 Cohort 1
- Group 2: Placebo Cohort 1
- Group 3: XXB750 Cohort 2
- Group 4: Placebo Cohort 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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