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Adult Congenital Heart Disease clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

View clinical trials related to Adult Congenital Heart Disease.

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Completed
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NCT ID: NCT04136379 Completed - Clinical trials for Congenital Heart Disease

Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

Start date: September 30, 2019
Phase:
Study type: Observational

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.