Systolic Heart FailurePhase 4NCT00348530
Carvedilol Versus Verapamil in Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy
A Phase 4 study testing Verapamil in people with Systolic Heart Failure and Myocardial Disease, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Accumulated clinical and experimental data suggest that dysfunctional coronary microcirculation plays a pivotal role in the progression of heart failure despite an optimal therapy used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systolic Heart Failure, Myocardial Disease, Cardiomyopathy
- What is being tested?
- Verapamil
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2006to Dec 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure (NYHA II and III; LV ejection fraction, ≤ 35%) secondary to non-ischemic cardiomyopathy. Stable condition at least 6 months before enrollment on conventional therapy (beta-blockers, ACE inhibitors and diuretics).
Who cannot join
- improvement in clinical status on conventional therapy in out-patients period preceded hospitalization
- any changes narrowing epicardial coronary arteries in coronary angiography,
- insulin dependent diabetes,
- valvular heart disease (except the relative mitral regurgitation),
- endocrine disease,
- lack of written informed consent,
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- significant renal and liver diseases,
- drug or alcohol abuse,
- therapy with steroids or calcium blockers within 3 months before screening
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Silesian Center for Heart Disease, IIIrd Department of Cardiology, Silesian Medical University
Zabrze, 41-800
Romuald Wojnicz, MD, PhD, +48-32-2732272, wojnicz@dom.zabrze.pl
Romuald Wojnicz, MD, PhD
About this study
Official title: Prospective, Randomized Comparison of Therapy With Verapamil or Carvedilol on Long-Term Outcomes of Patients With Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy
Accumulated clinical and experimental data suggest that dysfunctional coronary microcirculation plays a pivotal role in the progression of heart failure despite an optimal therapy used. Therefore, we hypothesize that improvement in microvascular function by calcium antagonist, verapamil may result in additional clinical benefit. Thus, the aim of this study is to compare the effect of treatment with verapamil or carvedilol on long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.
Read the detailed description
Heart failure, irrespective of its etiology may be viewed as a progressive disorder initiated by a different events and sustained by a multifaceted pathophysiological mechanisms. Regardless of the nature of the initiating events and optimized therapy used, loss of functioning cardiac myocytes developed and the disease progressed. One potential explanation for such progression is that not all pathological mechanisms underlying the disease are antagonized enough by currently used therapeutic strategy. Accordingly, impaired myocardial perfusion secondary to microvascular dysfunction has been postulated to play a major role in the progression of heart failure despite standard therapy for heart failure (1). It has been hypothesized that diffuse subendocardial ischemia due to altered coronary physiology may contribute to the global cardiac dysfunction seen in heart failure patients (2). Accordingly, coronary endothelial dysfunction at the microvascular and epicardial level in patients with acute-onset idiopathic dilated cardiomyopathy and chronic congestive heart failure has been reported (3,4) Thus, taking all mentioned above into account, the improvement in endothelial function and diminishing of subendocardial ischemia with calcium antagonists may be promising in terms of using these drugs for therapy of patients with stable chronic heart failure. The previous randomized study (5) and our long-term pilot study support this point of view.
- Neglia D, Michelassi C, Trivieri MG, et al. Prognostic role of myocardial blood flow impairment in idiopathic left ventricular dysfunction. Circulation 2002;105:186-193.
- Unverferth DV, Magorien RD, Lewis RP, et al. The role of subendocardial ischemia in perpetuating myocardial failure in patients with nonischemic congestive cardiomyopathy. Am Heart J 1983;105:176-179.
- Mathier MA, Rose GA, Fifer MA, et al. Coronary endothelial dysfunction in patients with acute-onset idiopathic dilated cardiomyopathy. J Am Coll Cardiol 1998;32:216-224.
- Chong AY, Blann AD, Patel J, et al. Endothelial dysfunction and damage in congestive heart failure. Relation of flow-mediated dilation to circulating endothelial cells, plasma indexes of endothelial damage, and brain natriuretic peptide. Circulation 2004;110:1794-1798.
- Figulla HR, Gietzen F, Zeymer U, et al. Diltiazem improves cardiac function and exercise capacity in patients with idiopathic dilated cardiomyopathy. Results of diltiazem in dilated cardiomyopathy trial. Circulation 1996;94:346-352.
- Conditions
- Systolic Heart Failure, Myocardial Disease, Cardiomyopathy
- Being tested
- Verapamil
- Keywords
- Systolic heart failure; Therapy; Cardiomyopathy
- Medical subject headings
- Heart Failure, Systolic, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP; LVEF(radionuclide ventriculography; LVFS; LVDD/LVSD, NYHA class, V02, 6 min walking test, MLWHFQ.
Secondary outcomes (1)
Death; Heart transplantation; Readmission to hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Investigators
- Romuald Wojnicz, MD, PhD, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348530
- Sponsor's protocol ID
- CavsBe.2006
- Status last verified
- Jan 2006
- First submitted
- 3 Jul 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of Therapy With Verapamil or Carvedilol on Long-Term Outcomes of Patients With Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00348530
- Acronym / sponsor ID
- CavsBe.2006
- Conditions
- Systolic Heart Failure, Myocardial Disease, Cardiomyopathy
- Keywords
- Systolic heart failure; Therapy; Cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2007
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accumulated clinical and experimental data suggest that dysfunctional coronary microcirculation plays a pivotal role in the progression of heart failure despite an optimal therapy used. Therefore, we hypothesize that improvement in microvascular function by calcium antagonist, verapamil may result in additional clinical benefit. Thus, the aim of this study is to compare the effect of treatment with verapamil or carvedilol on long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.
Detailed description
Heart failure, irrespective of its etiology may be viewed as a progressive disorder initiated by a different events and sustained by a multifaceted pathophysiological mechanisms. Regardless of the nature of the initiating events and optimized therapy used, loss of functioning cardiac myocytes developed and the disease progressed. One potential explanation for such progression is that not all pathological mechanisms underlying the disease are antagonized enough by currently used therapeutic strategy. Accordingly, impaired myocardial perfusion secondary to microvascular dysfunction has been postulated to play a major role in the progression of heart failure despite standard therapy for heart failure (1). It has been hypothesized that diffuse subendocardial ischemia due to altered coronary physiology may contribute to the global cardiac dysfunction seen in heart failure patients (2). Accordingly, coronary endothelial dysfunction at the microvascular and epicardial level in patients with acute-onset idiopathic dilated cardiomyopathy and chronic congestive heart failure has been reported (3,4) Thus, taking all mentioned above into account, the improvement in endothelial function and diminishing of subendocardial ischemia with calcium antagonists may be promising in terms of using these drugs for therapy of patients with stable chronic heart failure. The previous randomized study (5) and our long-term pilot study support this point of view.
- Neglia D, Michelassi C, Trivieri MG, et al. Prognostic role of myocardial blood flow impairment in idiopathic left ventricular dysfunction. Circulation 2002;105:186-193.
- Unverferth DV, Magorien RD, Lewis RP, et al. The role of subendocardial ischemia in perpetuating myocardial failure in patients with nonischemic congestive cardiomyopathy. Am Heart J 1983;105:176-179.
- Mathier MA, Rose GA, Fifer MA, et al. Coronary endothelial dysfunction in patients with acute-onset idiopathic dilated cardiomyopathy. J Am Coll Cardiol 1998;32:216-224.
- Chong AY, Blann AD, Patel J, et al. Endothelial dysfunction and damage in congestive heart failure. Relation of flow-mediated dilation to circulating endothelial cells, plasma indexes of endothelial damage, and brain natriuretic peptide. Circulation 2004;110:1794-1798.
- Figulla HR, Gietzen F, Zeymer U, et al. Diltiazem improves cardiac function and exercise capacity in patients with idiopathic dilated cardiomyopathy. Results of diltiazem in dilated cardiomyopathy trial. Circulation 1996;94:346-352.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic heart failure (NYHA II and III; LV ejection fraction, ≤ 35%) secondary to non-ischemic cardiomyopathy. Stable condition at least 6 months before enrollment on conventional therapy (beta-blockers, ACE inhibitors and diuretics).
Key exclusion criteria (9 listed)
- improvement in clinical status on conventional therapy in out-patients period preceded hospitalization
- any changes narrowing epicardial coronary arteries in coronary angiography,
- insulin dependent diabetes,
- valvular heart disease (except the relative mitral regurgitation),
- endocrine disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verapamil | Drug | – |
Primary outcome
NT-proBNP; LVEF(radionuclide ventriculography; LVFS; LVDD/LVSD, NYHA class, V02, 6 min walking test, MLWHFQ.
1 secondary outcome
Death; Heart transplantation; Readmission to hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silesian Center for Heart Disease, IIIrd Department of Cardiology, Silesian Medical University
Zabrze, Poland
Romuald Wojnicz, MD, PhD principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verapamil in people with Systolic Heart Failure and Myocardial Disease, run by Medical University of Silesia at 1 site in Poland.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Oct 2006. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP; LVEF(radionuclide ventriculography; LVFS; LVDD/LVSD, NYHA class, V02, 6 min walking test, MLWHFQ.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2006.