Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

Summary

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To confirm these retrospective analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF patients with reduced or mid-range ejection fractions (LVEF \<50%).

Conditions

• Heart Failure

Interventions

DRUG

Digoxin

Digoxin tablets will be given orally

DRUG

Placebos

Placebo tablets will be given orally

Sponsors & Collaborators

• Disphar International B.V.

  collaborator INDUSTRY

• Teva Nederland BV

  collaborator UNKNOWN

• Tiofarma BV

  collaborator UNKNOWN

• Netherlands Heart Foundation

  collaborator OTHER

• Werkgroep Cardiologische centra Nederland

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Michiel Rienstra, MD, PhD · University Medical Center Groningen

• Peter van der Meer, MD, PhD · University Medical Center Groningen

• Dirk J van Veldhuisen, MD, PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2025-11-13

Completion

2025-11-13

Countries

• Netherlands

Study Locations