RECRUITING

Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing prevalence. Cardiovascular congestion with resultant limitation in physical activity is the hallmark of chronic and decompensated HF. The current HF physiologic model suggests that congestion is the result of volume retention and, therefore, therapies (such as diuretics) have generally been targeted at volume overload. Yet therapeutic approaches to reduce congestion have failed to show significant benefit on clinical outcomes, potentially due to an untargeted approach of decongestive therapies. The investigators' preliminary work suggested a complimentary contribution of volume redistribution to the mechanism of cardiac decompensation. The investigators identified the splanchnic nerves as a potential therapeutic target and showed that short-term interruption of the splanchnic nerve signaling could have favorable effects on cardiovascular hemodynamics and symptoms. As part of the investigators' proposal, the investigators will test the safety and efficacy of prolonged splanchnic nerve block in a randomized, controlled, blinded study in patients with HF and reduced ejection fraction (HFrEF). The results will help test the hypothesis of volume redistribution as a driver of cardiovascular congestion and functional limitations and pave the way for splanchnic nerve blockade as a novel therapeutic approach to HF.

Official Title

Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)

Quick Facts

Study Start:2025-04-05
Study Completion:2029-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06733012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years
  2. * Established diagnosis of HFrEF with left ventricular ejection fraction \<50%
  3. * NYHA II-III symptoms
  4. * Stable HF drug regimen for the preceding 1 month
  5. * Wedge pressure \>/=15 mmHg at rest or \>/=20 mmHg with peak stress on the initial invasive exercise testing
  6. * Glomerular filtration rate ≥ 15 mL/min per 1.73 m2
  7. * Heart rate with activity such as the 6 min walk increases by at least 10 beats
  1. * Type I myocardial infarction within 3 months
  2. * Infiltrative (i.e., amyloid) or hypertrophic cardiomyopathy
  3. * Uncontrolled atrial (heart rate \>100bpm) or ventricular arrhythmia
  4. * Chronic oxygen use \>2L
  5. * Hypersensitivity to albumin and pregnancy
  6. * History or scoliosis
  7. * Orthostatic hypotension (including a drop of pulse pressure with standing of more than 10)

Contacts and Locations

Study Contact

Marat Fudim
CONTACT
919-681-5816
marat.fudim@duke.edu

Principal Investigator

Manesh Patel, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke
Durham, North Carolina, 27278
United States

Collaborators and Investigators

Sponsor: Duke University

  • Manesh Patel, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-05
Study Completion Date2029-05-01

Study Record Updates

Study Start Date2025-04-05
Study Completion Date2029-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure