Splanchnic nerve block for heart failure with reduced ejection fraction
Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
This study is testing whether a nerve block can help people with heart failure and reduced heart function feel better and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06733012 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a splanchnic nerve block on patients with heart failure and reduced ejection fraction (HFrEF). The study aims to address the limitations of current decongestive therapies by targeting the splanchnic nerves, which may play a role in volume redistribution and cardiac decompensation. Participants will receive either the nerve block or a sham-control procedure to evaluate the impact on cardiovascular hemodynamics and symptoms. The trial focuses on patients with stable heart failure who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of HFrEF and NYHA II-III symptoms.
Not a fit: Patients with recent myocardial infarction, certain cardiomyopathies, or uncontrolled arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of heart failure symptoms and better overall patient outcomes.
How similar studies have performed: While this approach is novel, preliminary work suggests potential benefits, but further validation is needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Established diagnosis of HFrEF with left ventricular ejection fraction \<50% * NYHA II-III symptoms * Stable HF drug regimen for the preceding 1 month * Wedge pressure \>/=15 mmHg at rest or \>/=20 mmHg with peak stress on the initial invasive exercise testing * Glomerular filtration rate ≥ 15 mL/min per 1.73 m2 * Heart rate with activity such as the 6 min walk increases by at least 10 beats Exclusion Criteria: * Type I myocardial infarction within 3 months * Infiltrative (i.e., amyloid) or hypertrophic cardiomyopathy * Uncontrolled atrial (heart rate \>100bpm) or ventricular arrhythmia * Chronic oxygen use \>2L * Hypersensitivity to albumin and pregnancy * History or scoliosis * Orthostatic hypotension (including a drop of pulse pressure with standing of more than 10)
Where this trial is running
Durham, North Carolina
- Duke — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Manesh Patel, MD — Duke University
- Study coordinator: Marat Fudim
- Email: marat.fudim@duke.edu
- Phone: 919-681-5816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.