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Sponsors and Collaborators: |
St. Luke's-Roosevelt Hospital Center Medtronic |
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Information provided by: | St. Luke's-Roosevelt Hospital Center |
ClinicalTrials.gov Identifier: | NCT00433043 |
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 |
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Congestive Heart Failure |
Drug: Beta blocker (carvedilol or metoprolol succinate) Procedure: CRT (cardiac resynchronization therapy) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Beta-Blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System |
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 |
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1: Active Comparator
CRT and b-blocker uptitration to target dose
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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
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2: Active Comparator
CRT and continuation of entry b-blocker dose to 6 month evaluation
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
St. Lukes Roosevelt Hospital | |
New York, New York, United States, 10019 | |
United States, Pennsylvania | |
Jefferson Medical College | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Marrick L Kukin, MD | St. Luke's Roosevelt Hospitals |
Responsible Party: | St. Luke's Roosevelt Hospital ( Marrick Kukin, MD ) |
Study ID Numbers: | 06-107 |
Study First Received: | February 8, 2007 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00433043 History of Changes |
Health Authority: | United States: Institutional Review Board |
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) |
Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic Agents Cardiovascular Agents Metoprolol Antihypertensive Agents |
Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents Carvedilol |
Sympatholytics Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Metoprolol |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Metoprolol succinate Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |