Exercise tolerance of Chronic heart failure patients. MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Globifer Forte
Pharmaceutical Form: Tablet
INN or Proposed INN: Globifer Forte
Other descriptive name: HAEMOGLOBIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
King's College London
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 FEV1110 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. •To compare the change in serum iron levels 3 hours after oral FeSO4, Globifer Forte® or placebo tablets (oral absorption test). •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. ;Timepoint(s) of evaluation of this end point: week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •6MWD at week 12 between patients randomised to Globifer Forte® and those allocated to FeSO4. •DMT-1, FPN, and FLVCR2 expression on Caco-2 cells with sera from CHF patients. •Serum iron levels at 3 hours after oral Globifer Forte®, FeSO4, and placebo tablets. •Blood tests (e.g., iron status, NT-BNP, cytokines) at week 12. •Symptom status and quality of life (NYHA class, Kansas City Cardiomyopathy questionnaire [KCCQ], visual analogue fatigue scale) at week 12. •Cardiac structure and function on echo at week 12.;Timepoint(s) of evaluation of this end point: week 12. | — |
Countries
United Kingdom
Contacts
Public ContactDr Darlington Okonko
King's College London
Outcome results
None listed