Evaluation of "Early Disease" in Familial Dilated Cardiomyopathy

Evaluation of the efficacy of carvedilol to reduce echocardiographically-determined left ventricular dimensions in asymptomatic individuals with suspected early disease in familial dilated cardiomyopathy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000204640

Enrollment

Registered

2005-08-23

Start date

2003-07-10

Completion date

2007-05-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this study is to determine whether active treatment with carvedilol will improve short-term echocardiographic in asymptomatic individuals with familial dilated cardiomyopathy.

Interventions

This study involves a randomised, double-blind, placebo-controlled trial to determine whether oral administration of carvedilol over a 6-month period will reduce left ventricular dimensions in asymptomatic individuals who have a family history of dilated cardiomyopathy and echocardiographic changes that are suspected to represent early disease.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Positive family history, absence of heart failure symptoms, increased left ventricular end-diastolic diameter (>112% predicted) with or without mild impairment of systolic function (ejection fraction 40-55%).

Exclusion criteria

Chronic airflow limitation with >20% reversibility, heart rate less than 50 beats per minute, blood pressure <80/50mmHg.

Outcome results