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Completed

NCT Number: NCT03453151

Abdominal Nerve Blockade in Chronic Heart Failure.

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 90 mmHg or >180 mmHg
  • Infiltrative cardiomyopathy or constrictive cardiomyopathy
  • Chronic kidney disease stage 5
  • Pregnancy

Treatment and study plan

splanchnic nerve anesthesia with a local anesthetic

Drug

regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)

Primary outcomes

  1. 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.

  2. Mean Pulmonary Arterial Pressure (mPAP)

    Time frame: baseline, up to 1 hour

    Mean pulmonary arterial pressure will be measured before and after nerve block.

  3. 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.

Secondary outcomes

  1. Cardiac Index (CI)

    Time frame: baseline, up to 1 hour

    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.

  2. Urine Output

    Time frame: 2 hours pre-SNB, 2 hours post-SNB

    Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards

  3. Renal Biomarker Levels

    Time frame: 2 hours pre-SNB, 2 hours post-SNB

    BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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