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Arm 2 for Heart Failure

Q: Are individuals currently able to participate in this ongoing medical study?

Indeed, the details available on clinicaltrials.gov indicate that this ongoing research study is actively seeking eligible participants. The trial was initially posted for recruitment on December 12th, 2023 and underwent its most recent update on December 27th, 2023. A total of 720 patients will be enrolled across three designated sites.

Q: How large is the participant pool for this clinical investigation?

Indeed, the information available on clinicaltrials.gov confirms the active recruitment of patients for this clinical trial. The trial was first posted on December 12th, 2023 and last updated on December 27th, 2023. A total of 720 participants are being sought from three different sites.

Q: Has the fourth arm of this study received approval from the FDA?

Based on our assessment as a team at Power, we rate the safety of Arm 4 in this Phase 2 trial with a score of 2. While there is some available data indicating its safety, no evidence supporting efficacy has been observed thus far.

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Current symptom(s) of HF NYHA class II-III and LVEF < 50%

Receiving standard of care background HF therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 16

Awards & highlights

Study Summary

This trial will study the effectiveness, safety, and tolerability of XXB750 in patients with heart failure. It will be conducted at multiple centers and will last for 24 weeks. The trial will

Who is the study for?

This trial is for people with heart failure symptoms classified as NYHA class II-III and a left ventricular ejection fraction (LVEF) less than 50%. Participants must have elevated NT-proBNP levels and be on standard heart failure treatments. It's not specified who can't join.Check my eligibility

What is being tested?

The study tests different doses of XXB750 against Sacubitril/valsartan (a known heart failure medication) and a placebo over 24 weeks. Patients are randomly assigned to one of these options at multiple centers.See study design

What are the potential side effects?

While specific side effects aren't listed, common ones for new heart medications may include low blood pressure, kidney problems, high potassium levels, dizziness, or changes in heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have heart failure symptoms and my heart's pumping ability is reduced.

Select...

I am on standard heart failure treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in log NT-proBNP from baseline to Week 16

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arm 4Experimental Treatment1 Intervention

XXB750 High Dose

Group II: Arm 3Experimental Treatment1 Intervention

XXB750 Medium Dose

Group III: Arm 2Experimental Treatment1 Intervention

XXB750 Low Dose

Group IV: Arm 5Active Control1 Intervention

Sacubitril/valsartan, open label tablet

Group V: Arm 1Placebo Group1 Intervention

Placebo Treatment

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,589 Total Patients Enrolled

68 Trials studying Heart Failure

2,000,992 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to participate in this ongoing medical study?

"Indeed, the details available on clinicaltrials.gov indicate that this ongoing research study is actively seeking eligible participants. The trial was initially posted for recruitment on December 12th, 2023 and underwent its most recent update on December 27th, 2023. A total of 720 patients will be enrolled across three designated sites."

Answered by AI

How large is the participant pool for this clinical investigation?

"Indeed, the information available on clinicaltrials.gov confirms the active recruitment of patients for this clinical trial. The trial was first posted on December 12th, 2023 and last updated on December 27th, 2023. A total of 720 participants are being sought from three different sites."

Answered by AI

Has the fourth arm of this study received approval from the FDA?

"Based on our assessment as a team at Power, we rate the safety of Arm 4 in this Phase 2 trial with a score of 2. While there is some available data indicating its safety, no evidence supporting efficacy has been observed thus far."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

2023. "A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06142383.

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