NCT01676285

Brief Summary

Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized trial is to determine whether metoprolol succinate can revert cardiac dysfunction secondary to cirrhosis (cirrhotic cardiomyopathy), and prevent complications (renal dysfunction, mortality). A total of 100 patients with cirrhotic cardiomyopathy will be randomized (Group R) to receive metoprolol succinate or placebo; other 25 patients without cirrhotic cardiomyopathy (Group F) will only be followed up without medication. All patients will be evaluated in the beginning and again after six months. The assessment protocol includes clinical evaluation, electrocardiogram, echocardiogram, laboratory analysis and life quality questionaire. The end points will be cardiac remodeling, electrophysiologic changes, sympathetic activity, laboratory issue changes, renal function, quality of life, and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

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, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

August 28, 2012

Last Update Submit

September 9, 2014

Conditions

CirrhosisCirrhotic CardiomyopathyCardiac Remodeling

Keywords

Cirrhosiscirrhotic cardiomyopathycardiac remodelingcardiomyopathymetoprolol succinatebetablockers

Outcome Measures

Primary Outcomes (1)

  • Improvement of systolic function

    Systolic functional reserve is measured by aortic velocity time integral in echocardiographic at rest and stress with dobutamine.

    six months

Secondary Outcomes (6)

  • Improvement in left ventricular diastolic function

    six months

  • Renal function

    From randomization until six months

  • Serum level of BNP, catecholamines, plasmatic renin activity

    Six months

  • Mortality

    From randomization until six months of follow up

  • Quality of life

    Six months

  • +1 more secondary outcomes

Study Arms (3)

Metoprolol succinate

ACTIVE COMPARATOR

Metoprolol succinate

Drug: Metoprolol succinate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Follow up

NO INTERVENTION

Group without cirrhotic cardiomyopathy, only follow up without randomization.

Interventions

Metoprolol succinateDRUG
Also known as: Selozok
Metoprolol succinate
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • more than 18 years old.
  • must have signed the written informed consent.
  • nonalcoholic cirrhosis.

You may not qualify if:

  • Betablockers intolerance;
  • Diagnosis of other cardiomyopathy
  • Chronicle renal disease (Creatinine \> 2.5)
  • Heavy alcohol intake history
  • Presence of other disease with possible cardiac implication (infiltrative or storage disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo School of Medicine

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

FibrosisCardiomyopathies

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Fernando Bacal, MD, PhD

    University of Sao Paulo School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

BR(1)