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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01676285
Other study ID # 0010/11
Secondary ID
Status Completed
Phase Phase 3
First received August 28, 2012
Last updated September 9, 2014
Start date January 2012
Est. completion date March 2014

Study information

Verified date September 2014
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Commission of Ethic in Researches - CONEP
Study type Interventional

Clinical Trial 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.


Description:

Cirrhotic cardiomyopathy (CMC) is defined as a chronic cardiac dysfunction in patients with cirrhosis. Moreover, it is characterized by an abnormal and blunted response to pathological or pharmacological stress in the absence of any other associated cardiac disease. The diagnostic criteria are: baseline increased cardiac output, attenuated myocardial contractile response to stress, diastolic dysfunction, and electrophysiological repolarization abnormalities. It is suspected that cardiac dysfunction in cirrhosis contribute to the onset of complications in liver disease. We will investigate the effect of metoprolol succinate in the reversal of cardiac dysfunction and prevention of complications of cirrhosis in patients with cirrhotic cardiomyopathy. Furthermore, we want to study the influence of presence of CMC in the evolution of cirrhotic patients. The study will be prospective, randomized, double-blind, and placebo-controlled. The sample consists of 125 patients aged between 18 and 60 years old diagnosed with severe liver cirrhosis (Child B or C or MELD score above 10) with cirrhotic cardiomyopathy or not. Of these, 100 patients with cirrhotic cardiomyopathy will be randomized into two groups: group R1 (metoprolol succinate) and group R2 (placebo). Group F will consist of cirrhotic patients without cardiomyopathy and will not receive medication. Patients will be evaluated by clinical examination, resting electrocardiogram, 24-hour Holter, stress echocardiography and laboratory (brain natriuretic peptide (BNP), catecholamines, plasma renin activity, and troponin) at inclusion and after six months. The end points are: 1) Reversal of cardiac dysfunction in patients with cirrhotic cardiomyopathy, 2) Development of hepatorenal syndrome, 3) Reversal of the electrophysiologic abnormalities, 4)Changes in laboratory tests, and 5) Mortality.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date March 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- more than 18 years old.

- must have signed the written informed consent.

- nonalcoholic cirrhosis.

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Metoprolol succinate

placebo


Locations

Country Name City State
Brazil University of Sao Paulo School of Medicine Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of systolic function Systolic functional reserve is measured by aortic velocity time integral in echocardiographic at rest and stress with dobutamine. six months Yes
Secondary Improvement in left ventricular diastolic function six months No
Secondary Renal function From randomization until six months Yes
Secondary Serum level of BNP, catecholamines, plasmatic renin activity Six months No
Secondary Mortality From randomization until six months of follow up Yes
Secondary Quality of life Six months No
Secondary Electrophysiologic modifications QT prolongation R-R variability Six months No
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