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NCT06613477RECRUITINGIRB Ready

PK/PD of Digoxin in Infants With SVHD

Sponsored by Duke University

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
📊
1 of 20 participants interested
5% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic").

Who Can Participate

Inclusion Criteria

Diagnosis of single ventricle congenital heart disease 2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation 3. Age ≤ 30 days of life at time of stage 1 palliation 4. Age \< 6 months at time of enrollment 5. Require treatment with enteral digoxin per their treating medical provider 6. Informed consent obtained from parent(s) or legal guardian(s)

Exclusion Criteria

Prematurity (gestational age \<37 weeks) at birth 2. Serum creatinine \> 2 mg/dL at enrollment 3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment 4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment 5. Known hypersensitivity to digoxin or other forms of digitalis 6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment 7. Received digoxin prior to enrollment

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

20 participants

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Age Range

30 Days - 6 Months

Gender

ALL

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Sponsor

Duke University

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Durham

North Carolina

Location available
NOT_YET_RECRUITING

Charleston

South Carolina

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

🔒 Secure · 🏥 Expert Care

Looking for Single Ventricle Heart Disease Treatment in Durham?

Join others in North Carolina exploring innovative treatment options through clinical research

Single Ventricle Heart Disease Treatment Options in Durham, North Carolina

If you're searching for Single Ventricle Heart Disease treatment in Durham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Durham, Charleston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Single Ventricle Heart Disease. All study-related care is provided at no cost to participants.

Local Sites
2 locations in North Carolina
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Single Ventricle Heart Disease?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Single Ventricle Heart Disease

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Single Ventricle Heart Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06613477. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.