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

NCT00433043 | Terminated Phase 4

• 1 other identifier: 06-107
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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).

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose.

  6 months

Secondary Outcomes (13)

• Correlation of Optivol fluid measurement increases (decreased impedance) with symptomatic worsening of heart failure during beta blocker uptitration

  6 months

• Optivol measurements (decreased impedance, increase volume index) correlated with the need for adjusting diuretic therapy when uptitrating beta blocker dose

  12 months

• Functional improvements

  6 months

• Exercise - 6 minute walk

  6 months

• QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

CRT and b-blocker uptitration to target dose

Drug: Beta blocker (carvedilol or metoprolol succinate); Procedure: CRT (cardiac resynchronization therapy)

2

ACTIVE COMPARATOR

CRT and continuation of entry b-blocker dose to 6 month evaluation

Drug: Beta blocker (carvedilol or metoprolol succinate); Procedure: CRT (cardiac resynchronization therapy)

Interventions

Beta blocker (carvedilol or metoprolol succinate) DRUG

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.

1; 2

CRT (cardiac resynchronization therapy) PROCEDURE

Both arms

1; 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA III-IV
• QRS \> 120 msec
• On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd)

You may not qualify if:

• QRS \< 120 msec
• On target beta blocker dose

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Medtronic: collaborator

Study Sites (3)

St. Lukes Roosevelt Hospital

New York, New York, 10019, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Jefferson Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• 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.

  PMID: 15781026 BACKGROUND

• 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.

  PMID: 10376614 BACKGROUND

• 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.

  PMID: 11386263 BACKGROUND

• 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.

  PMID: 15152059 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Adrenergic beta-Antagonists; Carvedilol; Metoprolol; Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines; Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Marrick L Kukin, MD

  St. Luke's Roosevelt Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 9, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 30, 2015

Record last verified: 2014-01

Locations

US (3)