TerminatedPhase 4NCT00075179
Official study title

Natrecor in Pulmonary Hypertension

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNesiritide (Natrecor) and Right Heart Catheterization

The study team can explain what participation involves.

Who it may be forPulmonary Hypertension · Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 7, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 4
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Nesiritide (Natrecor); Procedure: Right Heart Catheterization
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Ages 18 to 85 years old. 2. Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's). 3. PHTN documented by Doppler Echocardiography ( Done with in last 30 days) 4. Must be able to give an informed consent.

Reasons someone may not be able to joinExclusion criteria

1. Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) \<90). 2. Active infection or sepsis as defined by fever and need for IV antibiotics. 3. Creatinine greater than 3.0 mg/dl 4. Significant valvular disease as a cause for the PHTN. 5. Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR \> 1.6. 6. Left Ventricle Ejection Fraction (LVEF) \<40% (must be done with in the last 30 days prior to signing consent). 7. Hypersensitivity to nesiritide or any of it's components.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 7, 2018. Always confirm current availability with the study team.

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