BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Beta blocker (carvedilol or metoprolol succinate) Procedure: CRT (cardiac resynchronization therapy) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Beta-Blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System |
- 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 ]
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 | |
| Principal Investigator: | Marrick L Kukin, MD | St. Luke's Roosevelt Hospitals |
More Information
Publications:
| Responsible Party: | Marrick Kukin, MD, St. Luke's Roosevelt Hospital |
| ClinicalTrials.gov Identifier: | NCT00433043 History of Changes |
| Other Study ID Numbers: | 06-107 |
| Study First Received: | February 8, 2007 |
| Last Updated: | May 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Luke's-Roosevelt Hospital Center:
|
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) |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Adrenergic beta-Antagonists Metoprolol Metoprolol succinate Carvedilol Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013