NCT00348530

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 18, 2006

Status Verified

January 1, 2006

First QC Date

July 3, 2006

Last Update Submit

October 17, 2006

Conditions

Systolic Heart FailureMyocardial DiseaseCardiomyopathy

Keywords

Systolic heart failure; Therapy; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

VerapamilDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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,
  • significant renal and liver diseases,
  • drug or alcohol abuse,
  • therapy with steroids or calcium blockers within 3 months before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silesian Center for Heart Disease, IIIrd Department of Cardiology, Silesian Medical University

Zabrze, 41-800, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure, SystolicCardiomyopathies

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Romuald Wojnicz, MD, PhD

    Medical University of Silesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2007

Last Updated

October 18, 2006

Record last verified: 2006-01

Locations

PL(1)