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Congestive Heart FailurePhase 4NCT00433043

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

A Phase 4 study testing Beta blocker (carvedilol or metoprolol succinate) and CRT (cardiac resynchronization therapy) in people with Congestive Heart Failure, run by St. Luke's-Roosevelt Hospital Center at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Congestive Heart Failure
What is being tested?
Beta blocker (carvedilol or metoprolol succinate) and CRT (cardiac resynchronization therapy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesUnited States
Study dates
Jan 2007to May 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • QRS < 120 msec
  • On target beta blocker dose

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • St. Lukes Roosevelt Hospital

    New York, New York, 10019

  • Jefferson Medical College

    Philadelphia, Pennsylvania, 19107

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Beta blocker (carvedilol or metoprolol succinate), CRT (cardiac resynchronization therapy)
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)
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • CRT (cardiac resynchronization therapy)Procedure or surgery

    Both arms

Study groups in NCT00433043
Study groupRoleWhat they receive
1Active comparatorCRT and b-blocker uptitration to target dose
Receives: Drug: Beta blocker (carvedilol or metoprolol succinate); Procedure: CRT (cardiac resynchronization therapy)
2Active comparatorCRT and continuation of entry b-blocker dose to 6 month evaluation
Receives: Drug: Beta blocker (carvedilol or metoprolol succinate); Procedure: CRT (cardiac resynchronization therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (13)

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

    Measured: 6 months

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

    Measured: 12 months

  3. Functional improvements

    Measured: 6 months

  4. Exercise - 6 minute walk

    Measured: 6 months

  5. QOL - NYHA, Minnesota LWHFQ, Symptom Assessment Questionnaire

    Measured: 6 months

  6. Ejection fraction

    Measured: 6 months

  7. LVEDVI

    Measured: 6 months

  8. Remodeling

    Measured: 6 months

  9. HF Hospitalizations/ Mortality

    Measured: 6 months

  10. Evaluation of LVESVI in patients who actually achieve target dose

    Measured: 6 months

  11. Comparison of LVESVI changes based on initial beta-blocker dose

    Measured: 6 months

  12. Plasma Brain natriuretic peptide (BNP) change

    Measured: 6 months

  13. 12 month comparison after Group 2 has been uptitrated.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionMay 2009
  4. Study completionMay 2009

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433043
Sponsor's protocol ID
06-107
Status last verified
Jan 2014
First submitted
8 Feb 2007
Last updated
30 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15781026

  • 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.

    PubMed 10376614

  • 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.

    PubMed 11386263

  • 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.

    PubMed 15152059

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beta blocker (carvedilol or metoprolol succinate) and CRT (cardiac resynchronization therapy) in people with Congestive Heart Failure, run by St. Luke's-Roosevelt Hospital Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433043, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.

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