Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125996
Status:
UNKNOWN
Last Update Posted:
2005-08-17
First Post:
2005-08-01
Brief Title:
Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
Sponsor:
National Heart and Lung Institute
Organization:
National Heart and Lung Institute
Study Overview
Official Title:
A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
Status:
UNKNOWN
Status Verified Date:
2005-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-center randomised single-blind physician prospective controlled study to assess the acute 8 weeks and chronic 16 weeks effects of intravenous IV iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure CHF
The hypotheses are
Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2
IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF
The hypotheses are
Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2
IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF
Detailed Description:
Study Phase and Design
Prospective two-centre randomized controlled open-label observer-blinded parallel-group study
Primary Objective
To evaluate the effect of intravenous IV iron supplementation on exercise tolerance as determined by peak VO2
Secondary Objectives
To evaluate the effects of IV iron supplementation on exercise duration left ventricular LV structure and function symptom status NYHA class Minnesota Living with Heart Failure Questionnaire MLHFQ and subjective fatigue score and haematological and biochemical haemoglobin Hb haematocrit Hct iron status N-BNP cytokines and oxidative stress indices
To evaluate the safety profile of IV iron in subjects with moderate to severe CHF
Sample Size
42 subjects 28 IV iron 14 placebo 50 anaemic and 50 non-anaemic
Prospective two-centre randomized controlled open-label observer-blinded parallel-group study
Primary Objective
To evaluate the effect of intravenous IV iron supplementation on exercise tolerance as determined by peak VO2
Secondary Objectives
To evaluate the effects of IV iron supplementation on exercise duration left ventricular LV structure and function symptom status NYHA class Minnesota Living with Heart Failure Questionnaire MLHFQ and subjective fatigue score and haematological and biochemical haemoglobin Hb haematocrit Hct iron status N-BNP cytokines and oxidative stress indices
To evaluate the safety profile of IV iron in subjects with moderate to severe CHF
Sample Size
42 subjects 28 IV iron 14 placebo 50 anaemic and 50 non-anaemic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13103L | None | None | None |
| FERRIC-Hef1 | None | None | None |
| RD010 | None | None | None |