Natrecor in Pulmonary Hypertension

NCT00075179 | Terminated Phase 4

• 1 other identifier: 2003-0562
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.

Conditions

Pulmonary Hypertension; Cancer; Lung Disease; Cardiothoracic Surgery

Keywords

Pulmonary hypertension; cancer; lung cancer; lung disease; cardiothoracic surgery; Nesiritide; Natrecor; CV Surgery; Lung Tumor

Outcome Measures

Primary Outcomes (1)

• Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN)

  Baseline and 15 and 30 minutes after end of procedure

Study Arms (1)

Nesiritide

EXPERIMENTAL

Nesiritide 0.01 mcg/kg/min by vein over 30 minutes during right heart catheterization procedure.

Drug: Nesiritide (Natrecor); Procedure: Right Heart Catheterization

Interventions

Nesiritide (Natrecor) DRUG

Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization.

Nesiritide

Right Heart Catheterization PROCEDURE

Small tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure.

Nesiritide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 85 years old.
• Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).
• PHTN documented by Doppler Echocardiography ( Done with in last 30 days)
• Must be able to give an informed consent.

You may not qualify if:

• Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) \<90).
• Active infection or sepsis as defined by fever and need for IV antibiotics.
• Creatinine greater than 3.0 mg/dl
• Significant valvular disease as a cause for the PHTN.
• Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR \> 1.6.
• Left Ventricle Ejection Fraction (LVEF) \<40% (must be done with in the last 30 days prior to signing consent).
• Hypersensitivity to nesiritide or any of it's components.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center, Department of Cardiology

MeSH Terms

Conditions

Hypertension, Pulmonary; Neoplasms; Lung Diseases; Lung Neoplasms

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Daniel J. Lenihan, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2004
• First Posted: January 6, 2004
• Study Start: December 31, 2003
• Primary Completion: March 28, 2006
• Study Completion: March 28, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)