The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

NCT05991128 | Unknown Phase 4

• 1 other identifier: Monofer-HFpEF
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.

Conditions

Heart Failure With Preserved Ejection Fraction; Iron Deficiencies; Acute Heart Failure

Keywords

Exercise capacity; Quality of life; Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walking distance

  The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.

  Up to 3 days

Secondary Outcomes (13)

• Change From Baseline in 6-minute walking distance

  At 2 weeks, 4weeks after IV iron injection

• Change From Baseline in the KCCQ Clinical Summary Score

  At 2 weeks, 4weeks after IV iron injection

• Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value

  At 3 days, 2weeks, 4weeks after IV iron injection

• Change From Baseline in NYHA Functional Class

  At 3 days, 2weeks, 4weeks after IV iron injection

• Change From Baseline in PGA quality of life questionnaire

  At 3 days, 2weeks, 4weeks after IV iron injection

Other Outcomes (3)

• Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)

  At 3 days, 2weeks, 4weeks after IV iron injection

• A rise of high-sensitivity C-reaction protein (hs-CRP) levels from baseline

  Up to 4 weeks

• Adverse Event after IV iron injection

  Up to 4 weeks

Study Arms (2)

Ferric derisomaltose

EXPERIMENTAL

Iron to be administered as ferric derisomaltose. The treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value. Where Hb ≥10 g/dL, dosage according to body weight is as follows: Body weight \<50 kg: 20 mg/kg; Body weight 50 to \<70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg. Where Hb \<10 g/dL, dosage according to body weight is as follows: Body weight \<50 kg: 20 mg/kg; Body weight 50 to \<70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg. Infused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \>1000mg

Drug: Ferric derisomaltose

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive normal saline 0.9% in analogy to treatment arm.

Drug: Placebo

Interventions

Ferric derisomaltose DRUG

After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule.

Also known as: Monofer, Iron (III) isomaltoside 1000

Ferric derisomaltose

Placebo DRUG

n the placebo group, patients will receive the equivalent number of normal saline injections.

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) ≥50% before randomization.
• Currently hospitalized for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalization, New York Heart Association (NYHA) class II - IV.N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP≥600 or BNP ≥200 pg/mL in atrial fibrillation prior to randomization
• Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:
• Systolic blood pressure≥100mmHg, without symptoms of hypotension;
• Stop using intravenous diuretics;
• Neither intravenous inotropic drugs or vasodilators were used (including nitrates).
• Subject is iron deficient defined as serum ferritin \<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \<20%.
• Able and willing to provide informed consent and accomplish 6 minutes-walking test.

You may not qualify if:

• Haematological criteria: ferritin \>400ug/L; haemoglobin \<9.0 g/dL, or \>13.5 g/dL (for female), 14.5g/dL (for male).
• Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
• Body weight\<35kg at randomization.
• Heart failure was secondary to valvular diseases or congenital heart diseases.
• History of acquired iron overload or hemochromatosis (or first-degree relative of haemochromatosis)
• Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).
• Non-iron deficiency anaemia.
• Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.
• Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.
• Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean heart rate\> 100 beats / min at rest).
• Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST \> 3x upper limit of normal.
• Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.
• Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.
• minutes-walking distance\>500m at baseline. 15.Treated with long-term oral high-dose or steroid-immunosuppression therapy. 16.Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).
• Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Chaoyang District, China

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric derisomaltose; Iron; Saline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ying Zhou, Dr

CONTACT

+86-13699164283; 929352903@qq.com

Peizhao Li, Dr

CONTACT

+86-18443151740; lipz7014@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

CN (1)