NCT01484327

Brief Summary

Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA. It should also be administered to patients with stage I after myocardial infarction. The low ejection fraction, especially after myocardial infarction is a strong indication for beta-blockers, as many studies indicate that administration of these drugs substantially reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and improve the operational phase for all categories of patients with heart failure. Since beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown these benefits and thus, only those have to be administered. The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol on cardiac function in patients with heart failure or reduced left ventricular ejection fraction after acute myocardial infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
Last Updated

November 1, 2023

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

November 23, 2011

Last Update Submit

October 31, 2023

Conditions

Heart FailureAcute Myocardial Infarction

Keywords

Heart FailureAcute Myocardial InfarctionLVEF

Outcome Measures

Primary Outcomes (1)

  • Change in Left Ventricular Ejection Fraction LVEF(%)

    Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.

    0 (baseline), 48 weeks (12 months)

Secondary Outcomes (2)

  • Number of study participants with Adverse Events

    0 (baseline), 24 weeks (6 months), 48 weeks (12 months)

  • Cardedilol dosage range

    0 (baseline), 24 weeks (6 months), 48 weeks

Study Arms (1)

Carvedilol, LVEF, Heart Failure

Patients with Heart Failure on carvedilol therapy measured for their LVEF value

Drug: Carvedilol

Interventions

CarvedilolDRUG

Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg

Also known as: Carvepen
Carvedilol, LVEF, Heart Failure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Heart Failure and post-MI LVEF\<40%

You may qualify if:

  • Patients visiting outpatient clinics.
  • Male or female patients over 18 years
  • Patients with mild heart failure and history of symptoms according to the instructions of the European Society of Cardiology (ESC)
  • Patients who entered the study have LVEF \<40% in echocardiography
  • Patients with new diagnosis of heart failure
  • Patients who have left ventricular ejection fraction after acute myocardial infarction \<40%
  • Patients who have signed the consent form for recording and processing of personal data.
  • Patients who are willing to comply with the requirements of the study

You may not qualify if:

  • Patients under 18 years
  • Patients with unstable chronic heart failure
  • Patients with unstable hemodynamic profiles
  • Patients with heart valve disease
  • Patients with hypertrophic cardiomyopathy
  • Patients with unstable angina or active myocarditis
  • Patients with contraindications to treatment with beta-adrenergic receptors
  • Patients who have not consented to recording and processing of personal the data.
  • Women pregnant or breastfeeding
  • Patients treated with carvedilol for less than one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology University Clinic

Alexandroupoli, Greece

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Dimitrios Tziakas, A Professor

    University General Hospital of Alexandroupolis, Cardiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 2, 2011

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 1, 2023

Record last verified: 2011-11

Locations

GR(1)