BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00433043
First received: February 8, 2007
Last updated: August 13, 2014
Last verified: February 2014

February 8, 2007
August 13, 2014
January 2007
May 2009   (final data collection date for primary outcome measure)
LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose.
Complete list of historical versions of study NCT00433043 on ClinicalTrials.gov Archive Site
  • Correlation of Optivol fluid measurement increases (decreased impedance) with symptomatic worsening of heart failure during beta blocker uptitration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Optivol measurements (decreased impedance, increase volume index) correlated with the need for adjusting diuretic therapy when uptitrating beta blocker dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Functional improvements [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exercise - 6 minute walk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • LVEDVI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Remodeling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HF Hospitalizations/ Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evaluation of LVESVI in patients who actually achieve target dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Comparison of LVESVI changes based on initial beta-blocker dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Plasma Brain natriuretic peptide (BNP) change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 12 month comparison after Group 2 has been uptitrated. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)
Beta-blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System

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).

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 dysynchrony 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Beta blocker (carvedilol or metoprolol succinate)
    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.
  • Procedure: CRT (cardiac resynchronization therapy)
    Both arms
  • Active Comparator: 1
    CRT and b-blocker uptitration to target dose
    Interventions:
    • Drug: Beta blocker (carvedilol or metoprolol succinate)
    • Procedure: CRT (cardiac resynchronization therapy)
  • Active Comparator: 2
    CRT and continuation of entry b-blocker dose to 6 month evaluation
    Interventions:
    • Drug: Beta blocker (carvedilol or metoprolol succinate)
    • Procedure: CRT (cardiac resynchronization therapy)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00433043
06-107
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Medtronic
Principal Investigator: Marrick L Kukin, MD St. Luke's Roosevelt Hospitals
St. Luke's-Roosevelt Hospital Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP