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New treatment option for Chronic Heart Failure
Official title Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
ClinicalTrials.gov ID: NCT06270498
What this study is testing
- What it's testing
- The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID). The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Chronic HF (New York Heart Association [NYHA] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with...
- LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit)
- Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for...
- TSAT \<20%
- Hemoglobin 10.0-16.0 g/dL
You likely can't join if
- Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing
- Exercise training program in the previous 3 months, or planned in the next 3 months
- Recent (\<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke
- Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis
- Atrial fibrillation or flutter with a ventricular response rate of \>100 beats per minute at rest
- Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents
See the full eligibility criteria
- Chronic HF (New York Heart Association [NYHA] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with no dose changes of HF drugs
- LVEF\<50% at screening visit (historical value can be used if performed within 6 months of screening visit)
- Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for patients in normal sinus rhythm; ≥1,000 pg/mL (or BNP ≥400 pg/mL) for...
- TSAT \<20%
- Hemoglobin 10.0-16.0 g/dL
- Rapid iron repletion with intravenous iron is not considered a clinical necessity by physicians after reviewing patient medical record (if anaemia is present, its grade is no more than mild)
- Age ≥18 years, male and female
- Willingness to provide informed consent
- people who decide to use single or dual contraceptive methods to avoid conceiving during the study period
- Neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing
- Exercise training program in the previous 3 months, or planned in the next 3 months
- Recent (\<3 month) acute coronary syndrome, coronary artery bypass surgery, percutaneous coronary interventions, transient ischemic attack, or stroke
- Severe valvular disease, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, acute myocarditis
- Atrial fibrillation or flutter with a ventricular response rate of \>100 beats per minute at rest
- Temperature ≤38 °C (oral or equivalent) or active infection as defined by current use of oral or intravenous antimicrobial agents
- Need for blood transfusion within the last month
- Hb\ 16 g/dL
- Rapid iron repletion with intravenous iron is considered a clinical necessity by physicians after reviewing patient medical record
- Documented active gastrointestinal bleeding
- Oral iron, i.v. iron or erythropoietin stimulating agent within the last 3 months
- eGFR ≤15 mL/min or on hemodialysis
- Chronic liver disease and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
- Active cancer
- Evidence of iron overload (ferritin \>400 ng/mL)
- Hypersensitivity to any of the study products or known severe allergies
- Participation in another study
- Low body weight (≤35 kg)
- Known or anticipated pregnancy in the next 4 months
- Need for forbidden medications
- Breastfeeding
- Consumption of iron-rich foods or any food that alter iron absorption (i.e. food rich in vitamin C) due to dietary requirements
- Any pathological condition or disease associated with a reduction or an impairment of intestinal iron absorption (i.e., prior gastrectomy, atrophic gastritis, bariatric surgery, coeliac disease)
The study team makes the final eligibility decision.
Where it's taking place
- Pisa, Tuscany, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pisa, Tuscany, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.