CLINICAL TRIALS PROFILE FOR DIGOXIN

All Clinical Trials for Digoxin

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.

Clinical Trial Conditions for Digoxin

Condition Name

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

Condition MeSH

Condition MeSH for Digoxin
Intervention	Trials
Atrial Fibrillation	24
Heart Failure	22
Breast Neoplasms	5
Arthritis, Rheumatoid	5

Clinical Trial Locations for Digoxin

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Digoxin

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Digoxin

Sponsor Name

Sponsor Name for Digoxin
Sponsor	Trials
Boehringer Ingelheim	14
Bristol-Myers Squibb	11
AstraZeneca	8

Sponsor Type

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

Digoxin: Clinical Trials, Market Analysis, and Projections

Introduction to Digoxin

Digoxin, one of the oldest drugs in cardiovascular medicine, has been used for decades to manage heart failure (HF) and atrial fibrillation (AF). Despite its long history, the efficacy and safety of digoxin, particularly at lower doses, continue to be subjects of ongoing research and clinical trials.

Current Clinical Trials: The DECISION Trial

One of the most significant ongoing clinical trials involving digoxin is the DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial. Here are the key points:

• Objective: The DECISION trial aims to investigate the efficacy and safety of low-dose digoxin in patients with chronic heart failure and reduced or mildly reduced left ventricular ejection fraction (LVEF)[1].
• Design: This is a randomized, double-blind, parallel-group, placebo-controlled event-driven outcome trial. Patients are randomized 1:1 to receive either low-dose digoxin or a matching placebo. The trial targets a serum digoxin concentration of 0.5-0.9 ng/ml through dose adjustments based on serum measurements[1].
• Endpoints: The primary endpoint is a composite of cardiovascular mortality and total HF hospitalizations or urgent hospital visits for worsening HF. All endpoints are adjudicated blindly by a Clinical Event Committee[1].
• Enrollment: As of December 2023, enrollment was completed with 1002 patients, who will be followed for a median of 3 years[1].

Historical Context and Previous Studies

Previous studies have provided mixed results regarding the use of digoxin:

• DIG Trial: An older trial showed that digoxin reduced HF hospitalizations but had no effect on mortality. However, the doses used in this trial may have been too high, leading to potential toxicity[4].
• AFFIRM Trial: A post hoc analysis of the AFFIRM trial suggested that digoxin use was associated with higher all-cause mortality, particularly in patients with atrial fibrillation. However, this analysis was not randomized to individual rate-control drugs, which limits its conclusions[3].

Market Analysis and Projections

The global digoxin market is experiencing steady growth driven by its continued use in cardiovascular medicine.

Market Size and Growth

• Current Market Size: The global digoxin market was valued at US$ 62 million in 2024[2][5].
• Projected Growth: The market is expected to grow to US$ 74 million by 2030, with a Compound Annual Growth Rate (CAGR) of 3.1% during the forecast period of 2024-2030[2][5].

Key Players and Market Share

• Leading Companies: The main players in the digoxin market include Vital Labs and Alchem, which together occupy a significant market share. The top three companies in the market account for about 88% of the market share[2].
• Market Segmentation: The market is segmented by type, application, and region, with detailed forecasts and competitive landscapes provided in market research reports[2][5].

Clinical Uses of Digoxin

Digoxin remains a crucial medication in the management of certain cardiovascular conditions:

• Heart Failure: Digoxin is used for symptom relief in patients with heart failure and reduced LVEF. It helps in improving symptoms and reducing hospitalizations, although its effect on mortality is still under investigation[1][4].
• Atrial Fibrillation: Digoxin is recommended for long-term rate control in patients with paroxysmal, persistent, or permanent atrial fibrillation. However, its use must be carefully managed due to the risk of toxicity and potential adverse effects on mortality[3][4].

Management of Toxicity

Digoxin has a narrow therapeutic window, and managing its toxicity is critical:

• Therapeutic Window: The therapeutic range for serum digoxin concentrations is generally considered to be between 0.6-1.2 ng/mL, although symptoms of toxicity can occur within this range[4].
• Monitoring: Regular monitoring of serum digoxin levels and clinical signs of toxicity is essential to prevent adverse effects. The DIG trial highlighted that patients with serum concentrations above 1.2 ng/mL were more likely to experience toxicity[4].

Key Takeaways

• Clinical Trials: The DECISION trial is ongoing to evaluate the efficacy and safety of low-dose digoxin in heart failure patients.
• Market Growth: The global digoxin market is projected to grow at a CAGR of 3.1% from 2024 to 2030.
• Clinical Uses: Digoxin is used for heart failure and atrial fibrillation, but its use must be carefully managed to avoid toxicity.
• Market Players: Vital Labs and Alchem are among the leading companies in the digoxin market.

FAQs

What is the primary objective of the DECISION trial?

The primary objective of the DECISION trial is to investigate the efficacy and safety of low-dose digoxin in patients with chronic heart failure and reduced or mildly reduced left ventricular ejection fraction (LVEF).

What is the projected market size of digoxin by 2030?

The global digoxin market is expected to reach US$ 74 million by 2030.

Which companies are the main players in the digoxin market?

The main players in the digoxin market include Vital Labs and Alchem.

What is the therapeutic window for serum digoxin concentrations?

The therapeutic range for serum digoxin concentrations is generally considered to be between 0.6-1.2 ng/mL.

What are the common clinical uses of digoxin?

Digoxin is used for symptom relief in heart failure patients with reduced LVEF and for long-term rate control in patients with atrial fibrillation.

Sources

1. Efficacy and safety of low-dose digoxin in patients with heart failure ... - PubMed
2. Digoxin Market, Report Size, Worth, Revenue, Growth, Industry ... - Valuates Reports
3. Findings from post hoc propensity-matched analysis of the AFFIRM ... - European Heart Journal
4. Digoxin: current clinical uses and management of toxicity - British Journal of Cardiology
5. Digoxin Market Size, Growth, Forecast 2024-2030 (By Type, By application, By Company) - OpenPR

Last updated: 2025-01-02