Heart Failure Clinical Trial
Official title:
The Influence of Beta Blocker Therapy on the Hemodynamic Response to Inotrope Infusion in Patients With Acute Decompensated Heart Failure
NCT number | NCT01971944 |
Other study ID # | 11-1985 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2010 |
Est. completion date | October 2018 |
Verified date | November 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized
patients who are receiving Beta Blocker Participants: Patients who are admitted to the
General Cardiology and Heart Failure Services at the University of North Carolina Hospitals
with acute decompensated heart failure, who have maintained steady state concentrations of
beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team
to require pulmonary artery catheter placement and inotropic therapy with dobutamine or
milrinone by continuous infusion. Patients that are not currently receiving beta blocker
therapy will be enrolled for comparative purposes; however, any patient not at steady state
(on or off beta blocker therapy) will not be enrolled.
Procedures: After obtaining informed consent, patients will be assigned to the appropriate
sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol
and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine
followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm
attached, as part of the usual standard of practice). Baseline pulmonary artery catheter
hemodynamic parameters will be collected prior to administration of inotrope trial of
dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing
algorithm following initiation and dose titration. Dose titration will be determined by the
health care team based upon patient response or lack thereof and tolerability. Changes in
hemodynamic parameters in response to dobutamine or milrinone will be compared within study
groups. Additionally, data will continue to be collected on patients receiving not beta
blocker therapy for comparative purpose.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Patients = 18 years of age and English-speaking who are admitted to the General Cardiology or Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure (ADHF). - Patients deemed by the health care team to require hemodynamic monitoring with a pulmonary artery catheter and inotropic therapy. Patients receiving at least 3 doses of continued beta blocker therapy with carvedilol, metoprolol succinate, or metoprolol tartrate and patients receiving no beta blocker therapy or have missed at least 5 doses of beta-blocker therapy. Exclusion Criteria: - Concomitant treatment with other beta blockers, non-selective alpha blockers (e.g. terazosin, prazosin, doxazosin), non-dihydropyridine calcium antagonists, antiarrhythmic agents except for chronic stables doses of amiodarone, dofetilide or mexiletine. - Use of inotropes or IV vasoactive agents within 7 days or at time of enrollment Patients with hemodynamically unstable arrhythmias (e.g., Systolic Blood Pressure (SBP) < 80, Heart Rate (HR) > 110), uncorrected primary valvular disease, or current mechanical support including left ventricular assist device (LVADs), Impella devices and balloon pumps - Patients who have missed more than 1 dose of beta blocker within 72 hours of starting inotrope - No subjects will be excluded based upon race, gender or ethnicity. |
Country | Name | City | State |
---|---|---|---|
United States | UNC Healthcare | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Bollano E, Täng MS, Hjalmarson A, Waagstein F, Andersson B. Different responses to dobutamine in the presence of carvedilol or metoprolol in patients with chronic heart failure. Heart. 2003 Jun;89(6):621-4. — View Citation
Lowes BD, Tsvetkova T, Eichhorn EJ, Gilbert EM, Bristow MR. Milrinone versus dobutamine in heart failure subjects treated chronically with carvedilol. Int J Cardiol. 2001 Dec;81(2-3):141-9. — View Citation
Metra M, Nodari S, D'Aloia A, Muneretto C, Robertson AD, Bristow MR, Dei Cas L. Beta-blocker therapy influences the hemodynamic response to inotropic agents in patients with heart failure: a randomized comparison of dobutamine and enoximone before and after chronic treatment with metoprolol or carvedilol. J Am Coll Cardiol. 2002 Oct 2;40(7):1248-58. — View Citation
Woolfrey SG, Hegbrant J, Thysell H, Fox PA, Lendrem DW, Lockwood GF, Lasher K, Rogers J, Greenslade D. Dose regimen adjustment for milrinone in congestive heart failure patients with moderate and severe renal failure. J Pharm Pharmacol. 1995 Aug;47(8):651-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Fick Cardiac Index ( Fick CI) from baseline to maximum tolerated dose of inotrope therapy | Dobutamine will be titrated every 2 hours as tolerated for a total of 3 titrations. Data will be collected over the 6 hour infusion. Milrinone titration timeframes are dependent on renal function and as tolerated by patients. A total of 3 titrations may occur as tolerated over incremental timeframes of 4, 12, 18 and 24 hours. Data will be collected over the 12-72 hours the patient will be receiving the milrinone infusion. |
baseline to maximum tolerated dose. (up to 6 hours) |
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