Heart Failure MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Trade Name: Digoxin
Product Name: Digoxin
Pharmaceutical Form: Tablet
INN or Proposed INN: DIGOXIN
CAS Number: 20830755
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Currently prescribed digoxin or discontinued previously due to intolerance. 2. Allergy to Ascorbic acid or lactose. 3. Estimated Glomerular Filtration Rate 5.5 mmol/dl. 7. Plasma magnesium level 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome measures will be the effect of digoxin therapy on i) the mean ventricular heart rate and ii) the heart rate variability measured using 24 Holter monitoring. Other measures of autonomic function will be measured such as heart rate turbulance and heat rate recovery after exercise. The study aims to investigate the role of low dose digoxin in the modern management of heart failure, particularly when added to beta blocker therapy, of which no clear evidence exists.; Secondary Objective: 1. Measure changes in systolic time intervals using acoustic cardiography or changes in heart contractility indices measured using impedance cardiography. 2. Changes in echocardiography measures of LV contractility and filling patterns. 3. Changes in NTproBNP level. 4. Changes in exercise varaibles during cardiorespiratory exercise testing. 5. Changes in functional status usi standardised heart failure questionnaire. 6. Changes in endothelial blood flow measured using laser and light spectroscopy ;Primary end point(s): i) Mean ventricular rate & ii) Heart rate variability (SDNN) on 24 hr Holter monitoring | — |
Countries
United Kingdom
Outcome results
None listed