Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Duke University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Number of participants with cardiovascular death
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Number of participants with cardiovascular death
Time Frame: 1 month post intervention
Number of participants with stroke
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
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
- Change in N terminal pro brain natriuretic protein (NT-proBNP) level(Baseline, 1, 3, 6, and 12 months)
- Change in pulmonary arterial mean pressure(Baseline to 3 months)
- Change in 6-minute walk test (6MWT)(Baseline, 1, 3, 6, and 12 months)
- Change in peak VO2 (oxygen uptake)(Baseline, 1, 3, 6, and 12 months)
- Change in echocardiographic parameters - ejection fraction (EF)(Baseline, 1, 3, and 6 months)
- Change in echocardiographic parameters - right ventricular end diastolic diameter(Baseline, 1, 3, and 6 months)
- Change in left ventricle to left atrial volume ratio (LVLAVR)(Baseline, 1, 3, and 6 months)
- Change in diastolic function as measured with lateral wall e' and E/e'(Baseline, 1, 3, and 6 months)