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Trial record 1 of 1 for:    Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency
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Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF) (PREFER-HF)

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ClinicalTrials.gov Identifier: NCT03833336
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Fundació La Marató de TV3
Information provided by (Responsible Party):
José Luis Morales Rull, MD, PhD, Institut de Recerca Biomèdica de Lleida

Brief Summary:
The purpose of the study is to evaluate whether the administration of iron to patients with heart failure and preserved ejection fraction results in an improvement of symptoms and functional class, in addition to evaluating whether oral iron is equivalent to intravenous iron to achieve this improvement.

Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Ferropenic Anemia Other: Placebo Drug: Ferric carboxymaltose Drug: Ferroglycine Sulfate Drug: Sucrosomial Iron Phase 3

Detailed Description:
Iron deficiency is one of the most prevalent co-morbid conditions in chronic heart failure. In the absence of any iron treatment, it is estimated that up to 50% of patients with heart failure have low levels of available iron. Treatment with intravenous iron improves exercise tolerance , quality of life , and reduces hospitalization in patients with chronic heart failure and reduced ejection fraction. However data on the effect of iron therapy in patients with heart failure with preserved ejection fraction are still lacking. The evidence related to oral iron therapy in HF is limited and no randomized trials compared oral iron vs no iron therapy in the absence of erythropoiesis-stimulating agents.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intravenous Iron Therapy With Ferric Carboxymaltose Compared With Oral Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Placebo Comparator: Placebo
normal saline solution plus oral lactose capsules
Other: Placebo
The group assigned to placebo will receive an infusion of normal saline solution plus oral lactose capsules identical to oral medication.

Active Comparator: Intravenous ferric carboxymaltose
Ferric carboxymaltose 500-1000 mg at 0,6,12,24 weeks ( adjusted by protocol)
Drug: Ferric carboxymaltose
The group assigned to receive intravenous iron will receive intravenous ferric carboxymaltose ajusted by weight and Hb levels according to study protocol plus oral placebo

Active Comparator: Oral iron A: ferroglycine sulfate
oral capsules of ferroglycine sulfate iron until week 24
Drug: Ferroglycine Sulfate
One group assigned to receive oral iron will receive two 100 mg oral capsule of ferroglycine sulfate plus intravenous placebo (normal saline solution)

Active Comparator: Oral iron B: sucrosomial iron
oral capsules of sucrosomial iron until week 24
Drug: Sucrosomial Iron
One group assigned to receive oral iron will receive or two oral capsule containing 30 mg of pyrophosphate sucrosomial iron plus intravenous placebo (normal saline solution)




Primary Outcome Measures :
  1. Six minute walking test distance [ Time Frame: 24 weeks ]
    Change in meters traveled in six minute walking test from baseline to week 24. An increase in distance is related to an improvement in functional capacity.


Secondary Outcome Measures :
  1. Change in New York Heart Association (NYHA) functional classification [ Time Frame: 24 weeks ]
    Change in New York Heart Association functional classification (I-IV) from baseline to week 24. A decrease is related to an improvement in functional capacity.

  2. Quality of Life assesed by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 24 weeks ]
    Change in Minnesota Living with Heart Failure questionnaire (0-100) from baseline to week 24. Questionnaire is s a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.

  3. Hospitalizations [ Time Frame: 24 weeks ]
    Rate of any, HF-related or other cardiovascular hospitalizations.

  4. Mortality [ Time Frame: 24 weeks ]
    All causes and cardiovascular mortality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with stable chronic HF (NYHA II/IV functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). In general, optimal pharmacological treatment should include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated.
  • Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization).
  • BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit.
  • Subject must be capable of completing the 6 minute walking test
  • Screening serum ferritin <100 ng/mL or 100-300 ng/mL with transferrin saturation <20%.
  • At least 18 years of age.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

  • Subject has known sensitivity to any of the products to be administered during dosing.
  • History of acquired iron overload.
  • History of erythropoietin-stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior torandomization.
  • Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron <75 mg/day is permitted.
  • Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
  • Known active bacterial infection.
  • Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
  • Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
  • Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion.
  • Subjects with known seropositivity to human immunodeficiency virus.
  • Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
  • Currently receiving systemic chemotherapy and/or radiotherapy.
  • Renal dialysis (previous, current, or planned within the next 6 months).
  • Unstable angina pectoris as judged by the investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute.
  • Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
  • Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
  • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s).
  • Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding.
  • Subject will not be available for all protocol-specified assessments.
  • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833336


Contacts
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Contact: Jose Luis Morales-Rull, MD,PhD 0034+616424858 jl.moralesrull@gmail.com

Locations
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Spain
Hospital Universitari Arnau de Vilanova Recruiting
Lleida, Spain
Contact: Jose Luis Morales-Rull, MD,PhD         
Sponsors and Collaborators
Institut de Recerca Biomèdica de Lleida
Fundació La Marató de TV3

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Responsible Party: José Luis Morales Rull, MD, PhD, José Luis Morales Rull, MD, PhD, Principal Investigator NUTRIMMIC group ( Nutrition Metabolism and Microbiota in Heart Failure), Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT03833336     History of Changes
Other Study ID Numbers: PREFER-HF
2016-003604-31 ( EudraCT Number )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Luis Morales Rull, MD, PhD, Institut de Recerca Biomèdica de Lleida:
heart failure
preserved ejection fraction
ferropenic anemia
Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Iron Metabolism Disorders
Cardiovascular Diseases
Anemia
Hematologic Diseases
Anemia, Hypochromic
Metabolic Diseases
Iron
Ferric Compounds
Glycine
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action