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

October 28, 2015 updated by: St. Luke's-Roosevelt Hospital Center

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • St. Lukes Roosevelt Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LVESVI change in patients with CRT/ increased dose of beta-blockers vs CRT and no change in beta-blocker dose.
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: Marrick L Kukin, MD, St. Luke's Roosevelt Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 8, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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