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Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)

NCT03833336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Heart Failure With Normal Ejection Fraction
  • Ferropenic Anemia

Interventions

OTHER

Placebo

The group assigned to placebo will receive an infusion of normal saline solution plus oral lactose capsules identical to oral medication.

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

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)

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)

Sponsors & Collaborators

  • Fundació La Marató de TV3

    collaborator OTHER

  • Institut de Recerca Biomèdica de Lleida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2024-09-15
Completion
2024-12-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833336 on ClinicalTrials.gov