Phase 2 Completed N=19 Treatment

Abdominal Nerve Blockade in Chronic Heart Failure.

Source: ClinicalTrials.gov NCT03453151 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcomePrimary: Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2) — 9.1; 9.8 mL/kg/min — p=0.053

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.

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

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

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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. Informational only — not medical advice.