Skip to content

Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Prospective, Randomized Comparison of Therapy With Verapamil or Carvedilol on Long-Term Outcomes of Patients With Chronic Heart Failure Secondary to Non-Ischemic Cardiomyopathy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374465
Enrollment
100
Registered
2006-09-11
Start date
2006-01-31
Completion date
2008-05-31
Last updated
2006-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy

Keywords

Dilated Cardiomyopathy, Heart Failure

Brief summary

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. 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. 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. 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.

Interventions

DRUGVerapamil
DRUGCarvedilol

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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 * Significant renal and liver disease * Alcohol abuse * Lack of written informed consent

Design outcomes

Primary

MeasureTime frame
Sserum level of NT-proBNP,LVEF, LV diameters, exercise capacity (NYHA, V02,6 min walking test, changes in quality of life (MLHFQ).
In addition to secondary endpoints efficacy, patients will be classified as improved if they meet an increase of > 10 percentage points in the absolute EF and decrease in NT-proBNP levels at least 50% as compared with baseline study.

Secondary

MeasureTime frame
Combined: mortality, heart transplantation, and readmission to hospital due to heart failure progression

Countries

Poland

Contacts

Primary ContactJan Wodniecki, MD, PhD
wojnicz@dom.zabrze.pl+48 32 2716471
Backup ContactEwa Nowalany Kozielska, MD, PhD
ewakozielska@wp.pl+48 32 2525767

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026