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BAY2413555 Dose 2 for Chronic Heart Failure (REMOTE-HF Trial)

Phase 1

Waitlist Available

Research Sponsored by Bayer

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 up to 56 days

Awards & highlights

REMOTE-HF Trial Summary

This trial is studying a new compound, BAY2413555, to see if it is safe and effective in treating people with chronic heart failure.

Eligible Conditions

Chronic Heart Failure

REMOTE-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555

Atrioventricular Block

REMOTE-HF Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment arm 2Experimental Treatment2 Interventions

Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Group II: Treatment arm 1Experimental Treatment1 Intervention

Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo to BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,956 Total Patients Enrolled

Frequently Asked Questions

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

Are geriatric patients eligible for the ongoing clinical trial?

"Participants must meet age criteria in order to be enrolled; the lower limit is set at 18 years old, with an upper boundary of 79."

Answered by AI

Has the FDA authorized utilization of BAY2413555 Dose 2?

"This is a Phase 1 study, so there is only minimal safety data available for BAY2413555 Dose 2 which merits it a score of 1."

Answered by AI

How many medical settings are hosting this investigation?

"Currently, there are 5 participating medical centres for this clinical trial. These include Accel Research Sites - Atlanta Clinical Research Centre in Atlanta, Capital Area Research LLC in Camp Hill and University of Nebraska Medical Centre in Omaha among other places."

Answered by AI

How many individuals will participate in this research endeavor?

"For this medical trial to be successful, 129 participants who meet the eligibility criteria must register. Potential enrollees have the option of enlisting at Accel Research Sites - Atlanta Clinical Research Center in Atlanta Georgia or Capital Area Research LLC based in Camp Hill Pennsylvania."

Answered by AI

Is my eligibility to partake in this research study being considered?

"This clinical trial is currently recruiting 129 individuals aged 18 to 79 with congestive heart failure. In order for applicants to be eligible, they must sign an informed consent form, have been diagnosed at least 3 months prior and present a New york Heart Association (NYHA) functional class I-III, as well as having had their left ventricular ejection fraction (LVEF) ≤ 45% documented within the past 12 months before Visit 1. Additionally all patients are required to undergo mandatory betablocker treatment with either Metoprolol, Carvedilol, Bisoprolol or Nebivolol on stable doses for 2"

Answered by AI

Are participants being enrolled into this research endeavor at present?

"The clinical trial is actively looking for participants, as indicated on the website of clinicaltrials.gov; it was first posted on September 20th 2022 and last revised November 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)

2022. "A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05532046.