NCT00305526

Brief Summary

This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 heart-failure

Geographic Reach
2 countries

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 9, 2007

Status Verified

August 1, 2007

First QC Date

March 21, 2006

Last Update Submit

August 8, 2007

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • LVEF changes between baseline and 6 months measured by Echocardiography

Secondary Outcomes (1)

  • increase % of patients with successful uptitration for Betablockers, reduce all cause hospitalizations and all cause mortality, reduce all cause mortality and heart failure hospitalizations, reduce all cause mortality and cardiovascular hospitalizations

Interventions

Contak Renewal (CRT-D)DEVICE

Eligibility Criteria

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

You may qualify if:

  • Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (\<25% of optimal dosage).

You may not qualify if:

  • chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Spedali Civili di Brescia

Brescia, 25100, Italy

Location

Istituto clinico Humanitas

Milan, Italy

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Antonio Curnis, MD

    Spedali Civili di Brescia, Brescia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

April 1, 2006

Study Completion

July 1, 2007

Last Updated

August 9, 2007

Record last verified: 2007-08

Locations

IT(2)CH(1)