Phase 2
N=19
Abdominal Nerve Blockade in Chronic Heart Failure.
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03453151 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) — 9.1; 9.8 mL/kg/min — p=0.053
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- splanchnic nerve anesthesia with a local anesthetic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) |
9.1; 9.8 | 0.053 |
| PRIMARY Mean Pulmonary Arterial Pressure (mPAP) |
40.5; 32.7 | <0.001 sig |
| PRIMARY Pulmonary Capillary Wedge Pressure (PCWP) |
28.3; 20.3; 34.8; 25.1 | <0.001 sig |
| SECONDARY Cardiac Index (CI) |
1.9; 2.3; 3.4; 3.8 | 0.077 |
| SECONDARY Urine Output |
167; 297 | — |
| SECONDARY Renal Biomarker Levels |
1.2; 1.2; 19; 18 | 0.250 |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of heart failure (HF)
- Symptomatic with dyspnea
- On a stable HF drug regimen
Exclusion Criteria
- 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 180 mmHg
- Infiltrative cardiomyopathy or constrictive cardiomyopathy
- Chronic kidney disease stage 5
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03453151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.