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Use of Nesiritide in the Management of Acute Diastolic Heart Failure

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00083772
First received: June 2, 2004
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.

Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.


Condition Intervention Phase
Heart Failure
Cardiovascular Disease
Acute Heart Failure
Diastolic Heart Failure
Congestive Heart Failure
Heart Disease
Drug: Nesiritide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Nesiritide in the Management of Acute Diastolic Heart Failure

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nesiritide
Drug: Nesiritide
Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
Other Name: Natrecor

  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083772

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jean-Bernard Durand, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00083772     History of Changes
Other Study ID Numbers: 2003-0782
Study First Received: June 2, 2004
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Heart failure
Diastolic heart failure
Congestive heart failure
Nesiritide
Natrecor
Left ventricular (LV) diastolic function
Fatigue
Shortness of breath
Edema
Heart disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure
Heart Failure, Diastolic
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014