Heart FailureNCT02669407
Splanchnic Nerve Anesthesia in Heart Failure
A study testing splanchnic nerve anesthesia with a local anesthetic and regional nerve block with a local anesthetic (Lidocaine) in people with Heart Failure, run by Duke University at 1 site in United States.
Trial summary
Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- splanchnic nerve anesthesia with a local anesthetic and regional nerve block with a local anesthetic (Lidocaine)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure (HF)
- Prior admissions for decompensated HF
- Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
- On a stable HF drug regimen prior to admission
- Anticipated hospital stay of at least 2 nights following catheterization procedure
Who cannot join
- Ongoing treatment with oral anticoagulation other than aspirin
- Immunosuppressive medications for solid organ transplant
- Acute MI (STEMI or NSTEMI) within 7 days
- Evidence of cardiogenic shock within 48 hours
- Systolic blood pressure < 90 mmHg or >180 mmHg
- Restrictive or constrictive cardiomyopathy
- Chronic kidney disease stage 3 or higher due to primary renal pathology
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Splanchnic Nerve Block for Acute Heart Failure
Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.
This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.
- Conditions
- Heart Failure
- Being tested
- splanchnic nerve anesthesia with a local anesthetic, regional nerve block with a local anesthetic (Lidocaine)
- 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 anesthesia with a local anestheticProcedure or surgery
regional nerve block of the splanchnic nerve
regional nerve block with a local anesthetic (Lidocaine)Drug
| Study group | Role | What they receive |
|---|---|---|
| Regional nerve anesthesia | Experimental | Regional nerve anesthesia of splanchnic nerve Receives: Procedure: splanchnic nerve anesthesia with a local anesthetic; Drug: regional nerve block with a local anesthetic (Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Venous Pressure
Measured: Baseline, 90 minutes
Pulmonary Arterial Mean Pressure
Measured: baseline, 30 minutes
Pulmonary Capillary Wedge Pressure
Measured: baseline, 30 minutes
Secondary outcomes (11)
Cardiac Index
Measured: baseline, 30 minutes
Ejection Fraction (LVEF)
Measured: Baseline, 90 minutes
Pulmonary Artery Systolic Pressure
Measured: Baseline, 30 minutes
Right Ventricular Diameter
Measured: Baseline, 30 mins
Left Ventricular Diameter
Measured: Baseline, 30 mins
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level
NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.
Measured: Baseline; 90 minutes
Urine Output Measured in ml Over 3 Hours
Measured: Baseline, post-procedure (0-3 hours)
Change in Blood Urea Nitrogen (BUN)
BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.
Measured: Baseline; 90 minutes
Change in Creatinine Level
Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.
Measured: Baseline; 90 minutes
Dyspnea as Measured on Likert Scale
The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.
Measured: 15, 30, 45, 60, 75, 90 minutes; 24 hours
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test
The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline, 90 minutes, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start1 Jan 2017
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669407
- Sponsor's protocol ID
- Pro00066528
- Status last verified
- May 2018
- First submitted
- 22 Jan 2016
- Last updated
- 6 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.
PubMed 33714749
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic Nerve Block for Acute Heart Failure
- ClinicalTrials.gov ID
- NCT02669407
- Acronym / sponsor ID
- Pro00066528
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 6 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.
This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional nerve anesthesia | Experimental | Procedure: splanchnic nerve anesthesia with a local anesthetic, Drug: regional nerve block with a local anesthetic (Lidocaine)Regional nerve anesthesia of splanchnic nerve |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of heart failure (HF)
- Prior admissions for decompensated HF
- Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
- On a stable HF drug regimen prior to admission
- Anticipated hospital stay of at least 2 nights following catheterization procedure
Key exclusion criteria (8 listed)
- Ongoing treatment with oral anticoagulation other than aspirin
- Immunosuppressive medications for solid organ transplant
- Acute MI (STEMI or NSTEMI) within 7 days
- Evidence of cardiogenic shock within 48 hours
- Systolic blood pressure < 90 mmHg or >180 mmHg
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 anesthesia with a local anestheticregional nerve block of the splanchnic nerve | Procedure or surgery | Regional nerve anesthesia |
| regional nerve block with a local anesthetic (Lidocaine) | Drug | Regional nerve anesthesia |
Primary outcome
Central Venous Pressure
Time frame: Baseline, 90 minutes
Pulmonary Arterial Mean Pressure
Time frame: baseline, 30 minutes
Pulmonary Capillary Wedge Pressure
Time frame: baseline, 30 minutes
11 secondary outcomes
Cardiac Index
Time frame: baseline, 30 minutes
Ejection Fraction (LVEF)
Time frame: Baseline, 90 minutes
Pulmonary Artery Systolic Pressure
Time frame: Baseline, 30 minutes
Right Ventricular Diameter
Time frame: Baseline, 30 mins
Left Ventricular Diameter
Time frame: Baseline, 30 mins
N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level
Time frame: Baseline; 90 minutes
Urine Output Measured in ml Over 3 Hours
Time frame: Baseline, post-procedure (0-3 hours)
Change in Blood Urea Nitrogen (BUN)
Time frame: Baseline; 90 minutes
Change in Creatinine Level
Time frame: Baseline; 90 minutes
Dyspnea as Measured on Likert Scale
Time frame: 15, 30, 45, 60, 75, 90 minutes; 24 hours
Change in Clinical Symptoms, as Measured by 6 Minute Walk Test
Time frame: Baseline, 90 minutes, 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33714749Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 anesthesia with a local anesthetic and regional nerve block with a local anesthetic (Lidocaine) 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Dec 2019. 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. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Venous Pressure (time frame: Baseline, 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669407, which also lists 1 linked publication.
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 6 Dec 2019.