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Splanchnic nerve block for Chronic Heart Failure

Phase 2

Waitlist Available

Led By Marat Fudim, MD, MHS

Research Sponsored by Duke University

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 8 weeks

Awards & highlights

Study Summary

This trial is testing whether or not a splanchnic nerve block, which interrupts the sympathetic innervation to the splanchnic vasculature, can decrease cardiac congestion in patients with chronic heart failure.

Eligible Conditions

Chronic Heart Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Absence of Nerve Block Related Complications

Peak Exercise Wedge Pressure

Peak Pulmonary Arterial Pressure

Secondary outcome measures

Dyspnea - Visual Analog Scale (VAS)

Peak Oxygen Uptake

Resting Central Venous Pressure

+2 more

Side effects data

From 2021 Phase 2 trial • 5 Patients • NCT04575428

25%

Pulmonary hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Splanchnic Nerve Block

Trial Design

1Treatment groups

Experimental Treatment

Group I: Splanchnic nerve blockExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Splanchnic nerve block

2020

Completed Phase 2

~10

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,064 Total Patients Enrolled

Marat Fudim, MD, MHSPrincipal InvestigatorDuke Universtiy

Frequently Asked Questions

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

Is the enrollment for this experiment limited to individuals over 25 years of age?

"Patients over the age of consent and below 90 years old are eligible to partake in this clinical trial."

Answered by AI

Is participation in this trial currently open to new recruits?

"Patients must have CHF and be within the appropriate age range (18-90) to take part in this investigation. In total, 6 individuals will form the sample size for this trial."

Answered by AI

Are there any available enrollments for this clinical trial?

"Yes, indeed. According to clinicaltrials.gov, this medical investigation has been ongoing since November 5th 2020 and is presently recruiting volunteers. 6 participants are needed from a single site for the duration of this study."

Answered by AI

Has the Food and Drug Administration validated Splanchnic nerve block as a treatment option?

"Based on our team's evaluation, splanchnic nerve block has been rated as 2 due to the presence of some safety data in Phase 2 trials but no efficacy-affirming information."

Answered by AI

What is the cumulative enrollment in this clinical research study?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was first made available on November 5th 2020, is currently recruiting participants. Approximately 6 people need to be sourced from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)

2020. "Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04575428.