BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)
Primary Purpose
Congestive Heart Failure
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Beta blocker (carvedilol or metoprolol succinate)
CRT (cardiac resynchronization therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart Failure, Beta blockers, Resynchronization, Congestive Heart Failure, NYHA III-IV, Candidate for BIVPM, Not on Target Dose (Coreg 25 Bid or Toprol XL 200 qd)
Eligibility Criteria
Inclusion Criteria:
- NYHA III-IV
- QRS > 120 msec
- On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd)
Exclusion Criteria:
- QRS < 120 msec
- On target beta blocker dose
Sites / Locations
- St. Lukes Roosevelt Hospital
- University of Rochester
- Jefferson Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
CRT and b-blocker uptitration to target dose
CRT and continuation of entry b-blocker dose to 6 month evaluation
Outcomes
Primary Outcome Measures
LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose.
Secondary Outcome Measures
Correlation of Optivol fluid measurement increases (decreased impedance) with symptomatic worsening of heart failure during beta blocker uptitration
Optivol measurements (decreased impedance, increase volume index) correlated with the need for adjusting diuretic therapy when uptitrating beta blocker dose
Functional improvements
Exercise - 6 minute walk
QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire
Ejection fraction
LVEDVI
Remodeling
HF Hospitalizations/ Mortality
Evaluation of LVESVI in patients who actually achieve target dose
Comparison of LVESVI changes based on initial beta-blocker dose
Plasma Brain natriuretic peptide (BNP) change
12 month comparison after Group 2 has been uptitrated.
Full Information
NCT ID
NCT00433043
First Posted
February 8, 2007
Last Updated
October 28, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00433043
Brief Title
BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)
Official Title
Beta-blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many heart failure patients are unable to reach target beta blocker doses. This study will address whether cardiac resynchronization therapy (CRT) will enable uptitration of beta-blockers to target doses and whether it will favorably affect remodeling by reducing left ventricular end systolic volume (LVESV), with measurable clinical benefit, beyond CRT alone (without changes in beta-blocker dose).
Detailed Description
Beta blockers have been proven to have benefit in heart failure (HF) patients with regard to morbidity and mortality. However, initiation and uptitration remains a challenge in many patients. Worsening of heart failure, symptomatic hypotension and symptomatic bradycardia all limit up-titration to the target doses that have been shown to have mortality benefits (carvedilol [Coreg] 25 mg bid, metoprolol succinate [Toprol-XL] 200 mg qd) in the large clinical trials (COPERNICUS, MERIT-HF).
It is debated whether the benefit of beta-blockade is solely due to heart rate reduction or more broadly from the cardiac, central and peripheral effects of blocking sympathetic activity. Clearly, there is a remodeling effect on the dilated ventricle. Furthermore, patients with heart rates of 64 bpm or less are rarely begun on beta-blocker therapy. It is not known whether these patients should be given a pacemaker in order to then safely initiate beta-blocker therapy.
It is also clear that isolated right ventricular pacing can have deleterious effects on ventricular dyssynchrony and symptomatic heart failure despite medical therapy. Biventricular pacing (BIVPM), also known as cardiac resynchronization therapy (CRT), is the pacing mode of choice for patients with wide QRS complexes and symptomatic HF.
It is hypothesized that CRT therapy allows for increased Beta -blocker dose (or initiation of beta-blocker in patients previously intolerant) with improved NYHA, ejection fraction, and remodeling effects. The synergy between two established heart failure therapies requires further evaluation in a prospective randomized trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure, Beta blockers, Resynchronization, Congestive Heart Failure, NYHA III-IV, Candidate for BIVPM, Not on Target Dose (Coreg 25 Bid or Toprol XL 200 qd)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
CRT and b-blocker uptitration to target dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
CRT and continuation of entry b-blocker dose to 6 month evaluation
Intervention Type
Drug
Intervention Name(s)
Beta blocker (carvedilol or metoprolol succinate)
Intervention Description
Both groups get CRT. Group 1 is uptitrated to target dose beta blocker after CRT. Group 2 maintains their b-blocker dose from study entry.
Intervention Type
Procedure
Intervention Name(s)
CRT (cardiac resynchronization therapy)
Intervention Description
Both arms
Primary Outcome Measure Information:
Title
LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation of Optivol fluid measurement increases (decreased impedance) with symptomatic worsening of heart failure during beta blocker uptitration
Time Frame
6 months
Title
Optivol measurements (decreased impedance, increase volume index) correlated with the need for adjusting diuretic therapy when uptitrating beta blocker dose
Time Frame
12 months
Title
Functional improvements
Time Frame
6 months
Title
Exercise - 6 minute walk
Time Frame
6 months
Title
QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire
Time Frame
6 months
Title
Ejection fraction
Time Frame
6 months
Title
LVEDVI
Time Frame
6 months
Title
Remodeling
Time Frame
6 months
Title
HF Hospitalizations/ Mortality
Time Frame
6 months
Title
Evaluation of LVESVI in patients who actually achieve target dose
Time Frame
6 months
Title
Comparison of LVESVI changes based on initial beta-blocker dose
Time Frame
6 months
Title
Plasma Brain natriuretic peptide (BNP) change
Time Frame
6 months
Title
12 month comparison after Group 2 has been uptitrated.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NYHA III-IV
QRS > 120 msec
On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd)
Exclusion Criteria:
QRS < 120 msec
On target beta blocker dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marrick L Kukin, MD
Organizational Affiliation
St. Luke's Roosevelt Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Lukes Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Jefferson Medical College
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15781026
Citation
Aranda JM Jr, Woo GW, Conti JB, Schofield RS, Conti CR, Hill JA. Use of cardiac resynchronization therapy to optimize beta-blocker therapy in patients with heart failure and prolonged QRS duration. Am J Cardiol. 2005 Apr 1;95(7):889-91. doi: 10.1016/j.amjcard.2004.12.023.
Results Reference
background
PubMed Identifier
10376614
Citation
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.
Results Reference
background
PubMed Identifier
11386263
Citation
Packer M, Coats AJ, Fowler MB, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Castaigne A, Roecker EB, Schultz MK, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med. 2001 May 31;344(22):1651-8. doi: 10.1056/NEJM200105313442201.
Results Reference
background
PubMed Identifier
15152059
Citation
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
Results Reference
background
Learn more about this trial
BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)
We'll reach out to this number within 24 hrs