Contemporary Heart Failure Management : A Randomised, Placebo-Controlled Trial to Measure the Effects of Low Dose Digoxin on Haemodynamics and Symptoms in Patients with Heart Failure - Contemporary Heart Failure Management : The Added Role of Digoxi

Phase 1

• Conditions: Heart Failure; MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure

• Registration Number: EUCTR2007-006660-30-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-10-29
• Study Start: 2010-08-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Left ventricular ejection fraction = 45% measured by echocardiography.
2. NTproBNP >100 pmol/L
3. NYHA functional class II-IV.
4. Treated with beta blocking agents.
5. Clinically stable on maximally tolerated heart failure therapeutics for = 3 months.
6. All patients must be in sinus rhythm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Currently prescribed digoxin or discontinued previously due to intolerance.
2. Allergy to Ascorbic acid or lactose.
3. Estimated Glomerular Filtration Rate <30mls/min.
4. Resting heart rate < 60/min.
5. 2nd or 3rd degree heart block, sinus node disorder or known accessory pathway
or any other listed contraindications to digoxin in the British National Formulary
(BNF).
6. Plasma potassium level < 3.5mmol/dl or >5.5 mmol/dl.
7. Plasma magnesium level < 0.6 mmol/dl.
8. Pregnant or breastfeeding.
9. Allergy to adhesive pads.
10. Age <18 or > 90 years old.
11. History of hypertrophic/constrictive or restrictive cardiomyopathy.
12. Permanently ventricular paced.
13. Mechanical valve replacement.
14. MI or stroke in the preceding 3 months.
15. Haemodynamically significant valvular disease.
16. Enrolled in trials involving other medicinal products.
17. Any patient planning to undergo a surgical or interventional procedure which
falls within the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified