Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure

NCT01261065 | Completed Phase 4

• 1 other identifier: VA-CDA
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The overall hypothesis of this application is that the improvement in LV ejection performance following treatment with betablockers is due, at least in part, to improvement in intrinsic myocardial contractility.

Conditions

Heart Failure; Cardiomyopathy

Keywords

beta blockers; heart failure; contractility; remodeling

Outcome Measures

Primary Outcomes (1)

• Load independent measure of contractility: Left ventricular velocity of circumferential shortening to left ventricular end systolic stress ratio

  Mean velocity of circumferential fiber shortening (VCF) will be derived as = Left Ventricular Fractional shortening / Ejection Time.Left ventricular (LV) end-systolic stress will be calculated as = (\[1.35 × P × LV endsysolic diameter\]/(4 × LV posterior wall thickness in systole × (1+LV posterior wall thickness in systole /LV endsysolic diameter)))

  6 months

Secondary Outcomes (1)

• Left ventricular end diastolic and end systolic volumes, left ventricular end systolic stress, effective arterial elastance

  6 months

Interventions

carvedilol DRUG

Patients with heart failure and LVEF \< 35 % were treated with maximally tolerated dose of carvedilol for a period of six months. Target dose was 25 mg bid or 37.5 mg bid if patient's baseline weight \> 80 kg.

Also known as: coreg

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older.
• Man or nonpregnant women (only women who are postmenopausal, surgically sterile or practicing an acceptable method of contraception)
• Patients with dilated nonischemic cardiomyopathy with LVEF\< 35% and NYHA Class III-IVa heart failure
• Patients on standard stable medical therapy with Ace inhibitors (or hydralazine and nitrates or Angiotensin II Receptor blockers if Ace-intolerant), diuretics and or digoxin for at least 1 month prior to enrollment in the study.
• Heart failure symptoms have to be present for at least 3 months
• Written informed consent

You may not qualify if:

• Ischemic heart disease documented by cardiac catheterization with any coronary obstructive lesion \> 50% stenosis, history of myocardial infarction, coronary artery bypass surgery , percutaneous coronary angioplasty or stenting
• Uncorrected primary valvular disease, obstructive or restrictive cardiomyopathy.
• Systolic blood pressure \>170 or \<85 mm Hg or diastolic blood pressure \>100 mm Hg; heart rate \<50 bpm.
• Sick sinus syndrome or advanced heart block (unless treated by a pacemaker), symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable defibrillator
• Cor pulmonale, obstructive pulmonary disease requiring oral bronchodilator or steroid therapy
• Active malignancy, or a systemic or terminal disease that would limit physical function or survival during the trial
• Active and known drug or alcohol dependence or any factors that will interfere with the study conduct or interpretation of results.
• Clinically important hepatic or renal disease; or any condition other than heart failure that could limit survival
• Platelet count \<100 000 mm3 or white blood cell count \<3000 mm3, INR (international normalized ratio) \>1.7
• Current treatment with beta-blocker, beta-agonist, verapamil, chronic cyclic or continuous inotropic therapy, or use of an investigational drug within 30 days of entry into the challenge phase
• History of drug sensitivity or adverse reactions to beta-blockers
• Unwillingness to cooperate or give written informed consent, pregnant or lactating women

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Bozkurt B, Bolos M, Deswal A, Ather S, Chan W, Mann DL, Carabello B. New insights into mechanisms of action of carvedilol treatment in chronic heart failure patients--a matter of time for contractility. J Card Fail. 2012 Mar;18(3):183-93. doi: 10.1016/j.cardfail.2011.11.004. Epub 2011 Dec 22.

  PMID: 22385938 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Biykem Bozkurt, MD

  Michael E.DeBakey VA Medical Center, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2001
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)