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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433043
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : February 9, 2007
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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).

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Beta blocker (carvedilol or metoprolol succinate) Procedure: CRT (cardiac resynchronization therapy) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta-blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
CRT and b-blocker uptitration to target dose
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: 2
CRT and continuation of entry b-blocker dose to 6 month evaluation
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

Primary Outcome Measures :
  1. 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 Measures :
  1. Correlation of Optivol fluid measurement increases (decreased impedance) with symptomatic worsening of heart failure during beta blocker uptitration [ Time Frame: 6 months ]
  2. Optivol measurements (decreased impedance, increase volume index) correlated with the need for adjusting diuretic therapy when uptitrating beta blocker dose [ Time Frame: 12 months ]
  3. Functional improvements [ Time Frame: 6 months ]
  4. Exercise - 6 minute walk [ Time Frame: 6 months ]
  5. QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire [ Time Frame: 6 months ]
  6. Ejection fraction [ Time Frame: 6 months ]
  7. LVEDVI [ Time Frame: 6 months ]
  8. Remodeling [ Time Frame: 6 months ]
  9. HF Hospitalizations/ Mortality [ Time Frame: 6 months ]
  10. Evaluation of LVESVI in patients who actually achieve target dose [ Time Frame: 6 months ]
  11. Comparison of LVESVI changes based on initial beta-blocker dose [ Time Frame: 6 months ]
  12. Plasma Brain natriuretic peptide (BNP) change [ Time Frame: 6 months ]
  13. 12 month comparison after Group 2 has been uptitrated. [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00433043

United States, New York
St. Lukes Roosevelt Hospital
New York, New York, United States, 10019
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Marrick L Kukin, MD St. Luke's Roosevelt Hospitals

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT00433043     History of Changes
Other Study ID Numbers: 06-107
First Posted: February 9, 2007    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: January 2014

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Heart Failure
Beta blockers
Congestive Heart Failure, NYHA III-IV
Candidate for BIVPM
Not on Target Dose (Coreg 25 Bid or Toprol XL 200 qd)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists