Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186329
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2005-09-13
Brief Title:
BNP for Cardio-Renal Decompensation Syndrome BNP-CARDS
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
B-type Natriuretic Peptide for Cardio-Renal Decompensation Syndrome
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients with exacerbations of heart failure have significant concomitant kidney dysfunction The combination of these two conditions makes pharmacological management difficult In this study we plan to randomize patients with heart failure and kidney dysfunction to receive infusions of Natrecor B-type Natriuretic Peptide--which may be beneficial to the management of these two diseases--or placebo
Detailed Description:
Heart failure represents a growing epidemic in the United States Recent figures reveal that almost 5 million people have heart failure in the US alone with an incidence 550000 new diagnosesyear that has increased up to threefold over the last 25 years This growing incidence of heart failure is thought to be due to changing population demographics Rates of major risk factors for the disease-diabetes mellitus hypertension and renal insufficiency--have all been steadily increasing
Renal insufficiency causes particular difficulty for the management of heart failure Most CHF patients have a significant degree of renal insufficiency - both because the risk factors for the two diseases are the same but also because reduced cardiac output related to CHF leads to reduced glomerular filtration rate GFR Diuretics in escalating doses a cornerstone of therapy for CHF exacerbations can also lead to worsening renal function a continued inability to achieve an adequate diuresis and toxicity from the agents given
B-type Natriuretic Peptide BNP is a 32-amino acid peptide hormone secreted predominantly from the ventricles in response to increased pressure and volume It has several actions in vivo working as a diuretic natriuretic and as a systemic pulmonary vasodilator Natrecor is a recombinant peptide structurally identical to endogenous BNP approved for the treatment of decompensated heart failure
In the Vasodilation in the management of Acute Congestive Heart Failure VMACtrial therapy with Natrecor resulted in improvements in pulmonary capillary wedge pressure seen within 15 minutes of starting the therapy these improvements were significantly better than with intravenous nitroglycerine Patients also reported a greater improvement in dyspnea with Natrecor therapy than with placebo In a prior study our group has demonstrated that prolonged Natrecor infusions result in improved hemodynamic parameters for Stage D heart failure patients awaiting heart transplantations
Natrecor therapy holds theoretical value for patients with heart failure and concomitant renal insufficiency Prior experimental work has demonstrated that BNP infusions can increase diuresis natriuresis and importantly GFR in healthy subjects--all of which represent major objectives in the therapy of heart failure patients Many have also reported the clinical experience that renal function was preserved and diuresisnatriuresis more readily achieved in patients with heart failure exacerbations and renal insufficiency with the addition of Natrecor therapy However this potential use for Natrecor has not been rigorously tested
The study is a prospective double-blinded placebo controlled clinical trial Patients admitted with the medical diagnosis of CHF exacerbation and that meet study criteria will be randomized to receive Natrecor vs placebo 5 dextrose in water intravenous infusions for 48 hrsRandomization will occur in the pharmacy department Patients randomized to Natrecor will receive a 2mcgkg IV bolus followed by a continuous infusion of 001mcgkgmin Patients who have a net negative diuresis greater than 1 liter prior to initiation of Natrecor therapy will not receive a bolus dose given a greater risk of hypotension Those randomized to placebo will receive a dummy bolus and infusion of the same volume of 5 dextrose in water
100 subjects will be recruited Inclusion criteria include inpatient admission with the diagnosis of CHF exacerbation and have a calculated creatinine clearance between 15-60 mlmin using the Cockcroft-Gault equation Patients 18 years and older are eligible for the trial regardless of gender or ethnic background Exclusion criteria include hypotension SBP 90mmHg at time of enrollment severe hypertension SBP170 mmHg necessitating IV vasodilator therapy known allergy to Natrecor history of heart transplantation up-front use of inotropes and contraindications to vasodilator therapy such as severe aortic stenosis and mental incompetence meaning inability to provide informed consent
In addition to Stanford University Medical Center we are beginning data collection at the VA Hospital in Palo Alto CA
Initial nursing management of these subjects includes every 15 minute blood pressure monitoring for hypotension In such a case the IV infusion will be discontinued for 36 minutes half-life of Natrecor is 18 minutes and then restarted Clinical experience with Natrecor has proven this regime is usually effective
Renal insufficiency causes particular difficulty for the management of heart failure Most CHF patients have a significant degree of renal insufficiency - both because the risk factors for the two diseases are the same but also because reduced cardiac output related to CHF leads to reduced glomerular filtration rate GFR Diuretics in escalating doses a cornerstone of therapy for CHF exacerbations can also lead to worsening renal function a continued inability to achieve an adequate diuresis and toxicity from the agents given
B-type Natriuretic Peptide BNP is a 32-amino acid peptide hormone secreted predominantly from the ventricles in response to increased pressure and volume It has several actions in vivo working as a diuretic natriuretic and as a systemic pulmonary vasodilator Natrecor is a recombinant peptide structurally identical to endogenous BNP approved for the treatment of decompensated heart failure
In the Vasodilation in the management of Acute Congestive Heart Failure VMACtrial therapy with Natrecor resulted in improvements in pulmonary capillary wedge pressure seen within 15 minutes of starting the therapy these improvements were significantly better than with intravenous nitroglycerine Patients also reported a greater improvement in dyspnea with Natrecor therapy than with placebo In a prior study our group has demonstrated that prolonged Natrecor infusions result in improved hemodynamic parameters for Stage D heart failure patients awaiting heart transplantations
Natrecor therapy holds theoretical value for patients with heart failure and concomitant renal insufficiency Prior experimental work has demonstrated that BNP infusions can increase diuresis natriuresis and importantly GFR in healthy subjects--all of which represent major objectives in the therapy of heart failure patients Many have also reported the clinical experience that renal function was preserved and diuresisnatriuresis more readily achieved in patients with heart failure exacerbations and renal insufficiency with the addition of Natrecor therapy However this potential use for Natrecor has not been rigorously tested
The study is a prospective double-blinded placebo controlled clinical trial Patients admitted with the medical diagnosis of CHF exacerbation and that meet study criteria will be randomized to receive Natrecor vs placebo 5 dextrose in water intravenous infusions for 48 hrsRandomization will occur in the pharmacy department Patients randomized to Natrecor will receive a 2mcgkg IV bolus followed by a continuous infusion of 001mcgkgmin Patients who have a net negative diuresis greater than 1 liter prior to initiation of Natrecor therapy will not receive a bolus dose given a greater risk of hypotension Those randomized to placebo will receive a dummy bolus and infusion of the same volume of 5 dextrose in water
100 subjects will be recruited Inclusion criteria include inpatient admission with the diagnosis of CHF exacerbation and have a calculated creatinine clearance between 15-60 mlmin using the Cockcroft-Gault equation Patients 18 years and older are eligible for the trial regardless of gender or ethnic background Exclusion criteria include hypotension SBP 90mmHg at time of enrollment severe hypertension SBP170 mmHg necessitating IV vasodilator therapy known allergy to Natrecor history of heart transplantation up-front use of inotropes and contraindications to vasodilator therapy such as severe aortic stenosis and mental incompetence meaning inability to provide informed consent
In addition to Stanford University Medical Center we are beginning data collection at the VA Hospital in Palo Alto CA
Initial nursing management of these subjects includes every 15 minute blood pressure monitoring for hypotension In such a case the IV infusion will be discontinued for 36 minutes half-life of Natrecor is 18 minutes and then restarted Clinical experience with Natrecor has proven this regime is usually effective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPO 29675 | None | None | None |