Use of Nesiritide in the Management of Acute Diastolic Heart Failure

NCT00083772 | Terminated Phase 4

• 1 other identifier: 2003-0782
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure; Cardiovascular Disease; Acute Heart Failure; Diastolic Heart Failure; Congestive Heart Failure; Heart Disease

Keywords

Heart failure; Diastolic heart failure; Congestive heart failure; Nesiritide; Natrecor; Left ventricular (LV) diastolic function; Fatigue; Shortness of breath; Edema; Heart disease

Outcome Measures

Primary Outcomes (1)

• 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).

  2 Years

Study Arms (1)

1

EXPERIMENTAL

Nesiritide

Drug: Nesiritide

Interventions

Nesiritide DRUG

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

Also known as: Natrecor

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Publications (5)

• Krishnaswamy P, Lubien E, Clopton P, Koon J, Kazanegra R, Wanner E, Gardetto N, Garcia A, DeMaria A, Maisel AS. Utility of B-natriuretic peptide levels in identifying patients with left ventricular systolic or diastolic dysfunction. Am J Med. 2001 Sep;111(4):274-9. doi: 10.1016/s0002-9343(01)00841-5.

  PMID: 11566457 BACKGROUND

• Cheng V, Kazanagra R, Garcia A, Lenert L, Krishnaswamy P, Gardetto N, Clopton P, Maisel A. A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001 Feb;37(2):386-91. doi: 10.1016/s0735-1097(00)01157-8.

  PMID: 11216951 BACKGROUND

• Zile MR, Gaasch WH, Carroll JD, Feldman MD, Aurigemma GP, Schaer GL, Ghali JK, Liebson PR. Heart failure with a normal ejection fraction: is measurement of diastolic function necessary to make the diagnosis of diastolic heart failure? Circulation. 2001 Aug 14;104(7):779-82. doi: 10.1161/hc3201.094226.

  PMID: 11502702 BACKGROUND

• Mills RM, Hobbs RE, Young JB. "BNP" for heart failure: role of nesiritide in cardiovascular therapeutics. Congest Heart Fail. 2002 Sep-Oct;8(5):270-3. doi: 10.1111/j.1527-5299.2002.01154.x.

  PMID: 12368590 BACKGROUND

• Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. doi: 10.1001/jama.287.12.1531.

  PMID: 11911755 BACKGROUND

Related Links

• MD Anderson Cancer Center, Department of Cardiology

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Failure, Diastolic; Heart Diseases; Fatigue; Dyspnea; Edema

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

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

• Jean-Bernard Durand, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2004
• First Posted: June 3, 2004
• Study Start: May 17, 2004
• Primary Completion: April 24, 2006
• Study Completion: April 24, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11