Clinical trial NCT06733012: Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
Official title: Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Number of participants with cardiovascular death
timeFrame: 1 month post intervention
measure: Number of participants with acute myocardial infarction
timeFrame: 1 month post intervention
measure: Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention
timeFrame: 1 month post intervention
measure: Number of participants with stroke
timeFrame: 1 month post intervention
measure: Change in exercise pulmonary capillary wedge pressure (PCWP) post splanchnic nerve block (SNB)
timeFrame: Baseline to 3 months post splanchnic nerve block (SNB)
Secondary outcomes:
measure: Change in pulmonary arterial mean pressure
timeFrame: Baseline to 3 months
measure: Change in peak VO2 (oxygen uptake)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Change in 6-minute walk test (6MWT)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Change in N terminal pro brain natriuretic protein (NT-proBNP) level
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Change in echocardiographic parameters - ejection fraction (EF)
timeFrame: Baseline, 1, 3, and 6 months
measure: Change in echocardiographic parameters - right ventricular end diastolic diameter
timeFrame: Baseline, 1, 3, and 6 months
measure: Change in left ventricle to left atrial volume ratio (LVLAVR)
timeFrame: Baseline, 1, 3, and 6 months
measure: Change in diastolic function as measured with lateral wall e' and E/e'
timeFrame: Baseline, 1, 3, and 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: