CLINICAL TRIALS PROFILE FOR DIGOXIN PEDIATRIC

All Clinical Trials for Digoxin Pediatric

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000476 ↗	Digitalis Investigation Group (DIG)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-06-01	To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
NCT00000547 ↗	Enalapril After Anthracycline Cardiotoxicity	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-04-01	To determine if the chronic administration of enalapril, an inhibitor of angiotensin converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology patients who have received anthracyclines, and who are not currently on digoxin, diuretics, or vasodilators for heart failure.
NCT00000556 ↗	Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1995-03-01	To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00006330 ↗	Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	US Department of Veterans Affairs	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	VA Office of Research and Development	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.

Clinical Trial Conditions for Digoxin Pediatric

Condition Name

Condition Name for Digoxin Pediatric
Intervention	Trials
Healthy	39
Atrial Fibrillation	16
Healthy Volunteers	13
Heart Failure	12

Condition MeSH

Condition MeSH for Digoxin Pediatric
Intervention	Trials
Atrial Fibrillation	24
Heart Failure	22
Arthritis	5
Heart Diseases	5

Clinical Trial Locations for Digoxin Pediatric

Trials by Country

Trials by Country for Digoxin Pediatric
Location	Trials
United States	179
Germany	22
Canada	18
China	14
Japan	12

Trials by US State

Trials by US State for Digoxin Pediatric
Location	Trials
Texas	25
Florida	14
California	12
Ohio	11
New York	11

Clinical Trial Progress for Digoxin Pediatric

Clinical Trial Phase

Clinical Trial Phase for Digoxin Pediatric
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	18
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Digoxin Pediatric
Clinical Trial Phase	Trials
Completed	140
Not yet recruiting	27
Recruiting	25

Clinical Trial Sponsors for Digoxin Pediatric

Sponsor Name

Sponsor Name for Digoxin Pediatric
Sponsor	Trials
Boehringer Ingelheim	14
Bristol-Myers Squibb	11
Eli Lilly and Company	8

Sponsor Type

Sponsor Type for Digoxin Pediatric
Sponsor	Trials
Other	174
Industry	157
NIH	12

Digoxin in Pediatrics: Clinical Trials, Market Analysis, and Projections

Introduction to Digoxin in Pediatrics

Digoxin, a cardiac glycoside, is a critical medication in the management of various heart conditions, including atrial fibrillation, atrial flutter, and heart failure. In pediatric care, particularly for infants with congenital heart diseases, digoxin plays a vital role in improving heart function and reducing mortality rates.

Clinical Trials: Focus on Pediatric Populations

Several clinical trials are underway to better understand the pharmacokinetics, safety, and efficacy of digoxin in pediatric populations, especially those with single ventricle congenital heart disease (SVCHD).

Pharmacokinetics and Safety Profile

A study by Nemours Children's Health System aims to collect data on the safety effects and pharmacokinetics of digoxin in infants with SVCHD. This trial involves infants less than 6 months old and includes blood sample collection to measure digoxin levels and heart function biomarkers over a period of up to 7 months[1].

Enrollment and Study Design

The Pediatric Trial Network (PTN) is conducting a study that has rapidly approached its enrollment goal despite COVID-19-related delays. This study focuses on determining appropriate dosing and safety measures for digoxin in infants with SVCHD, a condition affecting about 40,000 infants born in the U.S. each year. The study aims to reduce the high mortality rate associated with this condition[3].

PK/PD Model-Based Dosing

A research study listed on ClinicalTrials.gov is designed to validate a pharmacokinetic/pharmacodynamic (PK/PD) model-based dosing regimen for digoxin in infants with SVCHD. This study collects blood samples and medical records to ensure that the dosing regimen achieves digoxin exposures consistent with package insert recommendations. The model suggests lower doses than currently recommended, highlighting the need for personalized dosing regimens[4].

Market Analysis: Global Digoxin Market

Market Size and Forecast

The global digoxin market was valued at USD 60 million in 2021 and is projected to reach USD 81.1 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.1% during this period. This growth is driven by the increasing prevalence of heart failures and the expanding reliability of digoxin in cardiac care[5].

Key Drivers and Restraints

• Market Drivers: The rising prevalence of cardiovascular diseases, an increasing geriatric population, and advancements in healthcare infrastructure are key drivers of the digoxin market. Improved diagnostics and heightened awareness of cardiac treatments also contribute to market growth[2].
• Market Restraints: Potential side effects of digoxin, stringent regulatory requirements, and the emergence of alternative therapies are significant restraints. High development costs and supply chain disruptions also impact market expansion[2].

Market Opportunities and Challenges

• Market Opportunities: Innovations in supply chain systems, targeting regions with inadequate healthcare access, and exploring government healthcare programs for collaborations are potential opportunities. Developing patient-customized dosing regimens and combination therapies can also enhance market growth[2].
• Market Challenges: Navigating complex clinical trial processes, ensuring drug safety and efficacy, and addressing supply chain disruptions are key challenges. The competitive landscape and the impact of healthcare policy changes on market stability also need careful consideration[2].

Therapeutic Insights and Applications

Cardiac Conditions Treated

Digoxin is primarily used to treat atrial fibrillation, atrial flutter, and heart failure. In pediatric care, it is crucial for managing heart rate and improving heart efficiency in infants with congenital heart diseases[2].

End Users and Administration Routes

The market for digoxin injections spans hospitals, clinics, and specialized cardiac centers. The drug is administered through various routes, including intravenous and intramuscular injections, and is a critical component of cardiac care protocols in hospital pharmacies, outpatient clinics, and emergency care units[2].

Innovations and Research Areas

Enhancing Bioavailability and Patient-Customized Dosing

Research is focused on enhancing the bioavailability of digoxin and developing patient-customized dosing regimens. The PK/PD model-based dosing study is a prime example of this, aiming to achieve optimal digoxin exposures tailored to individual patient needs[4].

Combination Therapies

Exploring combination therapies to maximize therapeutic benefits is another area of innovation. This involves combining digoxin with other medications to improve heart function and reduce the risk of complications in patients with heart disorders[2].

Regulatory and Safety Considerations

FDA Approval and Safety Monitoring

Digoxin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of heart failure in congenital heart disease and heart failure patients. However, ongoing studies are crucial for monitoring safety and efficacy, especially in pediatric populations where dosing regimens need precise validation[3].

Potential Side Effects and Risks

While digoxin is effective, it comes with potential side effects such as arrhythmias, nausea, and visual disturbances. Clinical trials and real-world studies are essential for identifying and mitigating these risks, particularly in vulnerable populations like infants[2].

Conclusion

Digoxin remains a vital medication in pediatric cardiac care, particularly for infants with single ventricle congenital heart disease. Ongoing clinical trials are crucial for optimizing dosing regimens and ensuring safety. The global digoxin market is expected to grow, driven by increasing cardiovascular disease prevalence and advancements in healthcare. However, it faces challenges such as regulatory hurdles and the emergence of alternative therapies.

Key Takeaways

• Clinical Trials: Ongoing studies focus on pharmacokinetics, safety, and efficacy of digoxin in pediatric populations.
• Market Growth: The global digoxin market is projected to grow at a CAGR of 3.1% from 2021 to 2031.
• Therapeutic Applications: Digoxin is used to treat atrial fibrillation, atrial flutter, and heart failure, with a focus on pediatric cardiac care.
• Innovations: Research areas include enhancing bioavailability, patient-customized dosing, and combination therapies.
• Regulatory Considerations: FDA approval and ongoing safety monitoring are critical for pediatric use.

FAQs

What is the primary focus of current clinical trials on digoxin in pediatric populations?

Current clinical trials are focused on determining the pharmacokinetics, safety, and efficacy of digoxin in infants with single ventricle congenital heart disease.

How is the global digoxin market expected to grow?

The global digoxin market is projected to grow from USD 60 million in 2021 to USD 81.1 million by 2031, with a CAGR of 3.1%.

What are the main drivers of the digoxin market?

The main drivers include the rising prevalence of cardiovascular diseases, an increasing geriatric population, and advancements in healthcare infrastructure.

What are some of the challenges faced by the digoxin market?

Challenges include potential side effects, stringent regulatory requirements, the emergence of alternative therapies, and supply chain disruptions.

What innovations are being explored in the use of digoxin?

Innovations include enhancing the bioavailability of digoxin, developing patient-customized dosing regimens, and exploring combination therapies.

Sources

1. Nemours Children's Health System, "Pharmacokinetics/Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease"[1].
2. 360iResearch, "Digoxin Injection Market Size & Share 2025-2030"[2].
3. Pediatric Trial Network, "Enrollment Goal Rapidly Approaches for PTN Digoxin Study"[3].
4. ClinicalTrials.gov, "PK/PD of Digoxin in Infants With SVHD"[4].
5. Business Research Insights, "Digoxin Market Size, Forecast - 2031 Report"[5].