A Study of Stellate Ganglion Block and / or Reserpine in Group 2 Pulmonary Hypertension

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Pulmonary hypertension Group 2 (PH 2) associated with left-sided heart disease is relatively common, is associated with a poor prognosis, and unfortunately there are no proven medical treatments beyond attempts at correcting the left sided heart disease. Many PH 2 patients have evidence of active constriction of blood vessels from increased nerve traffic. Use of agents or procedures which produce a reversible chemical blockage of this nerve traffic have not been systematically tested in PH 2. The investigators will test whether acute interruption of sympathetic nervous system tone, which local anesthetic block of the stellate ganglion in the neck, will improve PH2, and also test whether the high blood pressure drug reserpine, which blocks sympathetic nerve activity, will do so during a one month trial period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Lidocaine; Nitric Oxide; Reserpine

Criteria

Inclusion criteria:

• Prior right heart catheterization, with mean pulmonary artery pressure > 25 mm Hg, pulmonary capillary wedge pressure > 15 mm Hg, and diastolic pressure gradient (pulmonary artery diastolic pressure - mean pulmonary capillary wedge pressure) ≥ 7 mm Hg OR clinically suspected group 2 pulmonary hypertension from non-invasive testing with planned right heart catheterization (RHC).

• On stable diuretic therapy

• Able to attend end-study visit 4 weeks after study entry

Exclusion criteria:

• Anticipated surgery to correct heart lesion responsible for pulmonary hypertension

• Need for heparinization for right heart catheterization (not standard practice, but sometimes utilized)

• History of depression, or treatment with tricyclic anti-depressant, serotonin uptake inhibitor, monamine oxidase inhibitor

• Severe renal or hepatic impairment, creatinine clearance < 30 ml/minute or renal replacement therapy or post-kidney transplant, abnormal liver function with elevated enzymes> 1.5 times the upper limit of normal or prior liver transplant.

• Systolic blood pressure <100 mm Hg

• Heart rate < 60 beats per minute

• Inability to independently complete telephone follow-up at two weeks, and clinic end-study visit at 4 weeks.

• Pulmonary edema

• Infiltrative cardiomyopathy - amyloidosis

• Symptomatic orthostatic hypotension

• Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.

• Uncontrolled heartburn

• Prior surgery to the left neck, for example, carotid endarterectomy, or other surgery which would increase the risk of stellate ganglion block

• Known sensitivity, allergy, or contraindication to lidocaine, any local anesthetic, or reserpine