- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833336
Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF) (PREFER-HF)
February 6, 2019 updated by: José Luis Morales Rull, MD, PhD, Institut de Recerca Biomèdica de Lleida
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)
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jose Luis Morales-Rull, MD,PhD
- Phone Number: 0034+616424858
- Email: jl.moralesrull@gmail.com
Study Locations
-
-
-
Lleida, Spain
- Recruiting
- Hospital Universitari Arnau de Vilanova
-
Contact:
- Jose Luis Morales-Rull, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
normal saline solution plus oral lactose capsules
|
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)
|
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
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 weeks
|
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.
|
24 weeks
|
Hospitalizations
Time Frame: 24 weeks
|
Rate of any, HF-related or other cardiovascular hospitalizations.
|
24 weeks
|
Mortality
Time Frame: 24 weeks
|
All causes and cardiovascular mortality
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 23, 2017
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
June 1, 2020
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (ACTUAL)
February 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 6, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREFER-HF
- 2016-003604-31 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Normal Ejection Fraction
-
Medical University of South CarolinaCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection FractionUnited States
-
Massachusetts General HospitalRoche DiagnosticsRecruitingCardiovascular Risk Factor | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Heart Failure, Right Sided | Heart Failure With Mid Range Ejection FractionUnited States
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI); Beth Israel Deaconess Medical... and other collaboratorsActive, not recruitingHeart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Acute Congestive Heart FailureUnited States
-
Memorial Hospital of Rhode IslandUniversity of California, San Diego; National Heart, Lung, and Blood Institute... and other collaboratorsUnknownHeart Failure | Physical Activity | Elderly | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Women | Strength TrainingUnited States
-
CorAssist Cadiovascular Ltd.TerminatedHeart Failure With Normal Ejection Fraction
-
University of BaselClinical Trial Unit, University Hospital Basel, SwitzerlandRecruitingHigh-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)Heart Failure With Normal Ejection FractionSwitzerland
-
Goethe UniversityDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)CompletedHeart Failure With Normal Ejection FractionGermany
-
University Hospitals Coventry and Warwickshire...CompletedHeart Failure With Normal Ejection FractionUnited Kingdom
-
Corporal Michael J. Crescenz VA Medical CenterCompletedHeart Failure With Normal Ejection FractionUnited States
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States