Heart FailureSplanchnic XNCT06733012
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction
A study testing Splanchnic nerve block in people with Heart Failure, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Splanchnic nerve block
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2025to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke
Durham, North Carolina, 27278
Marat Fudim Asosciate Professor, 919-681-5816, marat.fudim@duke.edu
About this study
Official title: Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
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.
- Conditions
- Heart Failure
- Being tested
- Splanchnic nerve block, Sham-control procedure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splanchnic nerve blockDevice
Catheter based ablation on the right greater splanchnic nerve
Sham-control procedureOther
Sham-control ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| Splanchnic nerve ablation | Experimental | Catheter based ablation on the right greater splanchnic nerve Receives: Device: Splanchnic nerve block |
| Sham control | Sham comparator | Sham-control procedure Receives: Other: Sham-control procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiovascular death
Measured: 1 month post intervention
Number of participants with acute myocardial infarction
Measured: 1 month post intervention
Number of participants with major vascular complications resulting prolonged hospitalization or surgical intervention
Measured: 1 month post intervention
Number of participants with stroke
Measured: 1 month post intervention
Change in exercise pulmonary capillary wedge pressure (PCWP) 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.
Measured: Baseline to 3 months post splanchnic nerve block (SNB)
Secondary outcomes (8)
Change in pulmonary arterial mean pressure
Measured: Baseline to 3 months
Change in peak VO2 (oxygen uptake)
A higher peak VO2 indicates better fitness.
Measured: Baseline, 1, 3, 6, and 12 months
Change in 6-minute walk test (6MWT)
The distance a patient walks in 6 minutes is used to assess aerobic capacity and endurance.
Measured: Baseline, 1, 3, 6, and 12 months
Change in N terminal pro brain natriuretic protein (NT-proBNP) level
N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a protein produced by the heart that can help diagnose and monitor heart failure.
Measured: Baseline, 1, 3, 6, and 12 months
Change in echocardiographic parameters - ejection fraction (EF)
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.
Measured: Baseline, 1, 3, and 6 months
Change in echocardiographic parameters - right ventricular end diastolic diameter
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.
Measured: Baseline, 1, 3, and 6 months
Change in left ventricle to left atrial volume ratio (LVLAVR)
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.
Measured: Baseline, 1, 3, and 6 months
Change in diastolic function as measured with lateral wall e' and E/e'
An E/e' ratio of less than 8 is considered normal, while a ratio greater than 15 indicates increased left ventricle filling pressures.
Measured: Baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start5 Apr 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manesh Patel, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733012
- Sponsor's protocol ID
- PRO00114523
- Acronym
- Splanchnic X
- Status last verified
- May 2026
- First submitted
- 4 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic Nerve Modulation In Heart Failure (Splanchnic X)
- ClinicalTrials.gov ID
- NCT06733012
- Acronym / sponsor ID
- Splanchnic X / PRO00114523
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splanchnic nerve ablation | Experimental | Device: Splanchnic nerve blockCatheter based ablation on the right greater splanchnic nerve |
| Sham control | Sham comparator | Other: Sham-control procedureSham-control procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splanchnic nerve blockCatheter based ablation on the right greater splanchnic nerve | Device | Splanchnic nerve ablation |
| Sham-control procedureSham-control ablation procedure | Other | Sham control |
Primary outcome
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)
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manesh Patel, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splanchnic nerve block in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marat Fudim (919-681-5816, marat.fudim@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with cardiovascular death (time frame: 1 month post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.