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Heart FailurePhase 4NCT01261065

Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure

A Phase 4 study testing carvedilol in people with Heart Failure and Cardiomyopathy, run by Michael E. DeBakey VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiomyopathy
What is being tested?
carvedilol
How many people
55 participants
Where
1 siteUnited States
Study dates
Dec 2001to Oct 2005
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Michael E. DeBakey Veterans Affairs Medical Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

The immediate specific objectives of this application are two-fold: (1) to determine whether the observed improvement in LV ejection performance is due to alterations in intrinsic cardiac myocardial contractility and (2) to determine whether changes in LV contractile reserve following an infusion of intravenous milrinone can be used to predict a salutary response to beta-blockers. The immediate specific objectives of this proposal will be addressed in the following two Specific Aims: In Specific Aim 1, we will determine whether the observed improvement in LV ejection fraction following treatment with beta-blockers is due to changes in intrinsic myocardial contractility, as opposed to changes in LV remodeling (i.e. reduction in LV volume) or changes in LV loading conditions. Changes in LV function will be evaluated using proven indexes, one an ejection phase index: the relation of end-systolic stress (ESS) to the mean velocity of fiber shortening (VCF), considered a relatively load independent measure of contractility. Changes in LV structure will be evaluated using echocardiography. In Specific Aim 2, we will determine whether the salutary response to beta-blockers can be predicted by measuring "contractile reserve", defined as a change in contractility determined by the relation of the mean velocity of fiber shortening (VCF) to end-systolic stress (ESS) in response to intravenous milrinone infusion at the cardiac catheterization lab prior to the institution of beta-blockade. The response to treatment with beta-blockers will be assessed by measurement of LV ejection fraction and LV end-diastolic volume by echocardiography after 6 months of treatment with beta-blockers, and these measurements will be correlated with the respective changes in contractile reserve measurement at baseline.

Being tested
carvedilol
Keywords
beta blockers, heart failure, contractility, remodeling
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

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

  • carvedilolDrug

    Also called coreg

    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.

What is being measured

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

  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)))

    Measured: 6 months

Secondary outcomes (1)

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

    Measured: 6 months

Timeline

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

  1. First posted16 Dec 2010 (estimated)
  2. Study startDec 2001
  3. Primary completionOct 2005
  4. Study completionOct 2005

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01261065
Sponsor's protocol ID
VA-CDA
Status last verified
Sep 2025
First submitted
15 Dec 2010
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22385938

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing carvedilol in people with Heart Failure and Cardiomyopathy, run by Michael E. DeBakey VA Medical Center at 1 site 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Load independent measure of contractility: Left ventricular velocity of circumferential shortening to left ventricular end systolic stress ratio (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 NCT01261065, which also lists 1 linked publication.

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 26 Sep 2025.

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