drugset / Trial / NCT03453151
Abdominal Nerve Blockade in Chronic Heart Failure.
NaSingle-groupOpen-labelTreatment
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. 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.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2019-06-27
- Completion
- 2019-12-27
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.
- 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.
- Fudim 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Bupivacaine | Other / unclassified | — | — |
| Background | Lidocaine | Other / unclassified | — | — |