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NCT Number: NCT06733012

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke

Durham, North Carolina, 27278, United States

Location status: Recruiting

Location contact

Marat Fudim Asosciate Professor

CONTACT

[email protected]

919-681-5816

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Splanchnic nerve block

Device

Catheter based ablation on the right greater splanchnic nerve

Sham-control procedure

Other

Sham-control ablation procedure

Primary outcomes

  1. Number of participants with cardiovascular death

    Time frame: 1 month post intervention

  2. Number of participants with acute myocardial infarction

    Time frame: 1 month post intervention

  3. Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention

    Time frame: 1 month post intervention

  4. Number of participants with stroke

    Time frame: 1 month post intervention

  5. Change in exercise pulmonary capillary wedge pressure (PCWP) post splanchnic nerve block (SNB)

    Time frame: Baseline to 3 months post splanchnic nerve block (SNB)

    Pulmonary capillary wedge pressure (PCWP) is measured by inserting a catheter with a balloon tip into a central vein and advancing it into a branch of the pulmonary artery. The catheter measures changing pressures in the pulmonary vessels. The upper limit of normal for PCWP is 12 mm Hg.

Secondary outcomes

  1. Change in pulmonary arterial mean pressure

    Time frame: Baseline to 3 months

  2. Change in peak VO2 (oxygen uptake)

    Time frame: Baseline, 1, 3, 6, and 12 months

    A higher peak VO2 indicates better fitness.

  3. Change in 6-minute walk test (6MWT)

    Time frame: Baseline, 1, 3, 6, and 12 months

    The distance a patient walks in 6 minutes is used to assess aerobic capacity and endurance.

  4. Change in N terminal pro brain natriuretic protein (NT-proBNP) level

    Time frame: Baseline, 1, 3, 6, and 12 months

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a protein produced by the heart that can help diagnose and monitor heart failure.

  5. Change in echocardiographic parameters - ejection fraction (EF)

    Time frame: Baseline, 1, 3, and 6 months

    EF equals the amount of blood pumped out of the ventricle with each contraction (stroke volume or SV) divided by the end-diastolic volume (EDV), the total amount of blood in the ventricle.

  6. Change in echocardiographic parameters - right ventricular end diastolic diameter

    Time frame: Baseline, 1, 3, and 6 months

    Right ventricular end diastolic diameter indicates the size of the right ventricle when it is at its most expanded state. larger measurements potentially signifying right ventricular dilation.

  7. Change in left ventricle to left atrial volume ratio (LVLAVR)

    Time frame: Baseline, 1, 3, and 6 months

    LVLAVR is the calculated ratio between the volume of the left ventricle (LV) and the volume of the left atrium (LA) in the heart and indicates how much larger the left ventricle is compared to the left atrium. This ratio is often used to assess left ventricular filling pressures and can be a marker for potential heart conditions, particularly related to diastolic dysfunction.

  8. Change in diastolic function as measured with lateral wall e' and E/e'

    Time frame: Baseline, 1, 3, and 6 months

    An E/e' ratio of less than 8 is considered normal, while a ratio greater than 15 indicates increased left ventricle filling pressures.

Study contacts

Contact information is provided by the study sponsor or research team.

Marat Fudim

CONTACT

[email protected]

919-681-5816

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)

Acronym: Splanchnic X

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 13, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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