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 8, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
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)
- 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.
- 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.
- 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.
- Hospitalizations [ Time Frame: 24 weeks ]Rate of any, HF-related or other cardiovascular hospitalizations.
- Mortality [ Time Frame: 24 weeks ]All causes and cardiovascular mortality
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
|Contact: Jose Luis Morales-Rull, MD,PhDfirstname.lastname@example.org|
|Hospital Universitari Arnau de Vilanova||Recruiting|
|Contact: Jose Luis Morales-Rull, MD,PhD|