Heart FailurePhase 1/2NCT03453151
Abdominal Nerve Blockade in Chronic Heart Failure.
A Phase 1/2 study testing splanchnic nerve anesthesia with a local anesthetic in people with Heart Failure, run by Duke University at 1 site in United States.
Trial summary
Patients with chronic 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 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- splanchnic nerve anesthesia with a local anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 27 Dec 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure (HF)
- Symptomatic with dyspnea
- On a stable HF drug regimen
Who cannot join
- Ongoing treatment with oral anticoagulation other than aspirin
- Immunosuppressive medications for solid organ transplant
- Acute MI (STEMI or Type I NSTEMI) within 7 days
- Systolic blood pressure < 90 mmHg or >180 mmHg
- Infiltrative cardiomyopathy or constrictive cardiomyopathy
- Chronic kidney disease stage 5
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF
Patients with chronic 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.
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.
Patients will undergo detailed physiological testing.
- Conditions
- Heart Failure
- Being tested
- splanchnic nerve anesthesia with a local anesthetic
- 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 anestheticDrug
regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)
| Study group | Role | What they receive |
|---|---|---|
| Regional nerve anesthesia | Experimental | Not described Receives: Drug: splanchnic nerve anesthesia with a local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
Peak VO2 will be measured before and after nerve block.
Measured: baseline, up to 1 hour
Mean Pulmonary Arterial Pressure (mPAP)
Mean pulmonary arterial pressure will be measured before and after nerve block.
Measured: baseline, up to 1 hour
Pulmonary Capillary Wedge Pressure (PCWP)
Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.
Measured: baseline, up to 1 hour
Secondary outcomes (3)
Cardiac Index (CI)
Cardiac index will be measured at 20 Watts steady state and peak exercise. Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual.
Measured: baseline, up to 1 hour
Urine Output
Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards
Measured: 2 hours pre-SNB, 2 hours post-SNB
Renal Biomarker Levels
BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards.
Measured: 2 hours pre-SNB, 2 hours post-SNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 May 2018
- Primary completion27 Jun 2019
- Study completion27 Dec 2019
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 (3)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manesh Patel, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453151
- Sponsor's protocol ID
- Pro00090299
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2018
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kittipibul V, Ganesh A, Coburn A, Coyne BJ, Gray JM, Molinger J, Ray N, Podgoreanu M, McCartney SL, Mamoun N, Fitzhugh RC, Lurz P, Green CL, Hernandez AF, Patel MR, Fudim M. Splanchnic Nerve Modulation Effects on Surrogate Measures of Venous Capacitance. J Am Heart Assoc. 2023 Jul 18;12(14):e028780. doi: 10.1161/JAHA.122.028780. Epub 2023 Jul 14.
PubMed 37449573Fudim 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 33714749Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.
PubMed 32535123
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF
- ClinicalTrials.gov ID
- NCT03453151
- Acronym / sponsor ID
- Pro00090299
- Conditions
- Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Posted 24 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic 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.
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.
Patients will undergo detailed physiological testing.
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 | Drug: splanchnic nerve anesthesia with a local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of heart failure (HF)
- Symptomatic with dyspnea
- On a stable HF drug regimen
Key exclusion criteria (7 listed)
- Ongoing treatment with oral anticoagulation other than aspirin
- Immunosuppressive medications for solid organ transplant
- Acute MI (STEMI or Type I NSTEMI) within 7 days
- Systolic blood pressure < 90 mmHg or >180 mmHg
- Infiltrative cardiomyopathy or constrictive cardiomyopathy
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 with a local anesthetic (Lidocaine/Bupivacaine) | Drug | Regional nerve anesthesia |
Primary outcome
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
Time frame: baseline, up to 1 hour
Peak VO2 will be measured before and after nerve block.
Mean Pulmonary Arterial Pressure (mPAP)
Time frame: baseline, up to 1 hour
Mean pulmonary arterial pressure will be measured before and after nerve block.
Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: baseline, up to 1 hour
Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.
3 secondary outcomes
Cardiac Index (CI)
Time frame: baseline, up to 1 hour
Urine Output
Time frame: 2 hours pre-SNB, 2 hours post-SNB
Renal Biomarker Levels
Time frame: 2 hours pre-SNB, 2 hours post-SNB
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37449573Kittipibul V, Ganesh A, Coburn A, Coyne BJ, Gray JM, Molinger J, Ray N, Podgoreanu M, McCartney SL, Mamoun N, Fitzhugh RC, Lurz P, Green CL, Hernandez AF, Patel MR, Fudim M. Splanchnic Nerve Modulation Effects on Surrogate Measures of Venous Capacitance. J Am Heart Assoc. 2023 Jul 18;12(14):e028780. doi: 10.1161/JAHA.122.028780. Epub 2023 Jul 14.
- 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.
- Derived from this study: PubMed 32535123Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.
- 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. This study is not recruiting at the moment.
Manesh Patel 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 Phase 1/2 study testing splanchnic nerve anesthesia with a local anesthetic 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 3 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: finished, as of the sponsor's last update on 24 Jul 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2020). 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?
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) (time frame: baseline, up to 1 hour). 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 NCT03453151, which also lists 3 linked publications.
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 24 Jul 2020; AzTrials last refreshed its copy on 3 Nov 2026.