A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-ID trial)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521570-34-00

Enrollment

396

Registered

2026-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty with Iron Deficiency in Elderly Patients with Cardiovascular Disease

Brief summary

Difference in SPPB values assessed at month 12 (at the end of the treatment period) and at baseline.

Detailed description

Difference in EQ-5D-5L scores assessed at month 12 (at the end of the treatment period) and at baseline, Total number of falls during the 12-month treatment period, Total number of days spent in hospital during the 12-month treatment period

Interventions

DRUG0

DRUG9% Sodium Chloride–Braun

DRUG9 mg/ml

DRUGroztwór do infuzji

DRUGTardyferon

DRUG80 mg

DRUGtabletki powlekane o przedłużonym uwalnianiu

DRUGFerinject 50 mg żelaza/ml dyspersja do wstrzykiwań/infuzji.

DRUGPlacebo w postaci tabletek powlekanych

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in SPPB values assessed at month 12 (at the end of the treatment period) and at baseline.	—

Secondary

Measure	Time frame
Difference in EQ-5D-5L scores assessed at month 12 (at the end of the treatment period) and at baseline, Total number of falls during the 12-month treatment period, Total number of days spent in hospital during the 12-month treatment period	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 6, 2026