Globifer Forte in Heart Failure (GLOBIFER HF)

Phase 1

• Conditions: Exercise tolerance of Chronic heart failure patients.; MedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004704-19-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• =30 years of age
•Signed written informed consent
•Stable symptomatic CHF; NYHA II,III or ambulatory IV and LVEF =45% as assessed within the last 6 months using echocardiographic or magnetic resonance imaging techniques.
•On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
•Ferritin <100 ug/l (absolute iron deficiency) or 100-300 ug/l with TSAT <20% (functional iron deficiency) within 4 weeks of initial screening visit.
•Red cell folate and Vitamin B12 levels above the lower limit of normal according to local lab reference range within 4 weeks of initial screening visit (even if achieved with folate or vitamin B12 supplements).
•Negative pregnancy test in women of child-bearing age
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis.
•Known hypersensitivity to oral iron preparations.
•Patients with rare hereditary galactose intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
•Religious or other objections to bovine/animal products
•Known active infection, inflammation, bleeding, malignancy and haemolytic anaemia.
•History of chronic liver disease and/or AST >3 times the upper limit of the normal range within 4 weeks of initial screening visit, chronic lung disease with FEV1<50% predicted, myelodysplastic disorder, and known HIV/AIDS disease.
•Known gastrointestinal disorder or malabsorption syndrome
•Prior gastric surgery
•Recipient of immunosuppressive therapy or renal dialysis.
•Diabetes with estimated glomerular filtration rate < 30 mL/min/1.73m2 within 4 weeks of initial screening visit.
•History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
•Unstable angina pectoris as judged by the investigator, severe uncorrected non-functional valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, uncontrolled fast atrial fibrillation or flutter (>110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias.
•Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing.
•Pregnant, breast-feeding, or planning to get pregnant.
•Inability to comprehend study protocol
•Parallel participation in another clinical trial

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the effect of 3 months of Globifer Forte® treatment on exercise capacity, as quantified by the 6 minute walk distance (6MWD), in CHF patients with functional or absolute iron deficiency.;Secondary Objective: •To evaluate the effect of sera from CHF patients on DMT-1, FPN, HCP-1, HRG-1, and FLVCR2 protein expression on Caco-2 duodenal cell lines.<br>•To compare the change in serum iron levels 3 hours after oral FeSO4, Globifer Forte® or placebo tablets (oral absorption test).<br>•To evaluate the effect of 3 months of Globifer Forte® treatment on iron status, symptoms and quality of life in CHF patients with functional or absolute iron deficiency;Primary end point(s): •6MWD at week 12 between patients randomised to Globifer Forte® and those allocated to placebo.<br>;Timepoint(s) of evaluation of this end point: week 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •6MWD at week 12 between patients randomised to Globifer Forte® and those allocated to FeSO4.<br>•DMT-1, FPN, and FLVCR2 expression on Caco-2 cells with sera from CHF patients.<br>•Serum iron levels at 3 hours after oral Globifer Forte®, FeSO4, and placebo tablets. <br>•Blood tests (e.g., iron status, NT-BNP, cytokines) at week 12.<br>•Symptom status and quality of life (NYHA class, Kansas City Cardiomyopathy questionnaire [KCCQ], visual analogue fatigue scale) at week 12.<br>•Cardiac structure and function on echo at week 12.;Timepoint(s) of evaluation of this end point: week 12.