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The Use of Nesiritide in the Management of Acute Diastolic Heart Failure

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What is being tested

Nesiritide

Drug
Who is being recruted

Cardiovascular Diseases
+1

+ Heart Diseases
+ Heart Failure
From 18 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 17, 2004Actual date on which the first participant was enrolled.

Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue. Decreasing the pressure in the heart and lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure. It has also been shown to help decrease the pressure in the lungs. Before treatment starts, you will be asked questions about your medical history and about any medications you are currently taking. You will have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and routine blood tests (about 2 teaspoons). You will have an ultrasound on your heart called an echocardiogram to measure your heart function and the pressures in your lungs. Your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test. You may stop or sit down at any time during the test. This test is being done to evaluate your energy level. You will also be asked to complete a questionnaire about your symptoms. This questionnaire should take no more than 10 minutes to complete. In order to measure the pressure in your heart and lungs, you will have a procedure called a "right heart catheterization". This is a procedure that may have been done as part of your standard of care even if you were not enrolled in this study. For this procedure, a small tube will be placed in a vein in your neck. A longer tube will be inserted into the first tube and fed through the vein and into your heart. This tube will be used to measure the pressure in your heart and lungs. After the pressures are measured, you will receive treatment with nesiritide during the right heart catheterization procedure. Nesiritide will be given as a continuous infusion (for 48 hours) by vein. The pressures in your heart and lungs will be measured again at 15, 30, then 60 minutes after you begin to receive nesiritide. The tubes will then be removed from your heart. You will be awake during this procedure and lying flat on your back. An anesthetic will be used to numb the area of your neck where the tube is placed. The entire procedure (including treatment) should take no longer than 1 hour. You will have an ultrasound of your heart performed immediately before and after the right heart catheterization. Within 15 minutes of the end of the procedure the echocardiogram, the 6-minute walk test, and the questionnaire about your symptoms will be repeated and your breathing will be re-evaluated. The nesiritide infusion will remain going through a vein in your arm for the next 48 hours. During this infusion you will remain in the hospital on telemetry floor so that researchers can monitor your blood pressure and watch for irregular heartbeat. After you have received this drug for 48 hours, the drug will be stopped. Within 24 hours after stopping treatment, an echocardiogram and a 6-minute walk test will be performed. You will also answer questions about your breathing and your quality of life. These should take no more than 15 minutes of your time to complete. You will be taken off study if your condition gets worse or intolerable side effects occur. At 2 and 4 weeks after your hospitalization and the right heart procedure, you will have follow-up visits scheduled. At these visits, you will have a complete physical exam, and possibly have blood work done if required by the doctor as part of your routine care. A blood test to check a BNP (B-type natriuretic peptide) level will also be performed . This is a special blood test to give researchers information about your heart and how much extra fluid you may be carrying with you because of your heart disease. Only 1 teaspoon of blood is needed for this test although up to 3 teaspoons of blood may need to be drawn depending of what blood tests your doctor orders at the follow-up visits. This is an investigational study. Nesiritide is FDA approved and is commercially available for the treatment of heart failure. However, the use of nesiritide for diastolic heart failure is under research. About 20 patients will take part in this study. All will be enrolled at UTMDACC.

Official TitleThe Use of Nesiritide in the Management of Acute Diastolic Heart Failure 
NCT00083772
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
9 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Heart Failure
Heart Failure, Diastolic
Criteria

The patient population recruited for this study will include patients being admitted for acute congestive heart failure. Eligible patients include those who have near normal LV systolic function. Inclusion Criteria: * Age 18 to 85 years old * Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR * LVEF \> or = 40% on recent (\< or = 1 month) echo or MUGA * NYHA class III or IV on admission * Baseline systolic blood pressure \> 90 mm Hg * Baseline BNP level \> 100 pg/ml * Able to sign informed consent and return for follow-up assessments Exclusion Criteria: * Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) \<90 mm Hg) * Active infection/sepsis as defined by fever \> 101.5 F, currently on IV antibiotics * Creatinine greater than 3.0 mg/dl * LV ejection fraction \< 40% (must be done within the last 30 days prior to signing consent) * Significant valvular disease or constrictive cardiomyopathy * Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR \> 1.6 * Hypersensitivity to nesiritide or any of its components. * Pulmonary capillary wedge pressure (PCWP) \<16 mmHg * If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Nesiritide

Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

SuspendedNo study centers
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