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Recruiting NCT06733012

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Splanchnic nerve block, Sham-control procedure.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)

Overview

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.

Interventions

  • Device Splanchnic nerve block
    Catheter based ablation on the right greater splanchnic nerve
  • Other Sham-control procedure
    Sham-control ablation procedure

Primary outcome measures

  • Number of participants with cardiovascular death [Time frame: 1 month post intervention]
  • Number of participants with acute myocardial infarction [Time frame: 1 month post intervention]
  • Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention [Time frame: 1 month post intervention]
  • Number of participants with stroke [Time frame: 1 month post intervention]
  • Change in exercise pulmonary capillary wedge pressure (PCWP) post splanchnic nerve block (SNB) [Time frame: Baseline to 3 months post splanchnic nerve block (SNB)]
Secondary outcome measures (8)
  • Change in pulmonary arterial mean pressure [Time frame: Baseline to 3 months]
  • Change in peak VO2 (oxygen uptake) [Time frame: Baseline, 1, 3, 6, and 12 months]
  • Change in 6-minute walk test (6MWT) [Time frame: Baseline, 1, 3, 6, and 12 months]
  • Change in N terminal pro brain natriuretic protein (NT-proBNP) level [Time frame: Baseline, 1, 3, 6, and 12 months]
  • Change in echocardiographic parameters - ejection fraction (EF) [Time frame: Baseline, 1, 3, and 6 months]
  • Change in echocardiographic parameters - right ventricular end diastolic diameter [Time frame: Baseline, 1, 3, and 6 months]
  • Change in left ventricle to left atrial volume ratio (LVLAVR) [Time frame: Baseline, 1, 3, and 6 months]
  • Change in diastolic function as measured with lateral wall e' and E/e' [Time frame: Baseline, 1, 3, and 6 months]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke — Durham

Identifiers

NCT: NCT06733012 · PRO00114523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗