Iron-deficiency Clinical Trial
— IRON-HFpEFOfficial title:
Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction: A Prospective, Double-blind, Randomized, Placebo-controlled Trial
Verified date | July 2022 |
Source | Cantonal Hosptal, Baselland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to investigate the effects of treatment with intravenous ferric carboxymaltose on exercise tolerance measured as VO2peak in patients with HFpEF and iron deficiency, compared to placebo.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Informed consent as documented by signature - NYHA functional classes II-III - Signs and symptoms of chronic HF, such as: - Dyspnea - Paroxysmal nocturnal dyspnea - Reduced exercise tolerance - Fatigue - Extended recovery after exercising - Peripheral edema (lower leg, ankle) - EF (ejection fraction) >50% - Structural or functional changes in echocardiography: - Left atrial volume index (LAVI) >34 ml/m2 OR - Left ventricular mass index (LVMI) >115 g/m2 (men), >95 g/m2 (women) OR - E/E' (ratio between mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')) >13 AND mean E' septal and lateral wall <9 cm/s - NT-proBNP >125 pg/ml - At least 4 weeks on stable medical treatment or without signs and symptoms of cardiac decompensation - Iron deficiency defined as: - Ferritin <100 ng/ml OR - Ferritin <300 ng/ml with a transferrin saturation (TSAT) <20% Exclusion Criteria: - Age <18 years - Pregnancy or lactation - Life-expectancy <6 months - Planned cardiac interventions in the following 6 months - Unstable angina pectoris - Uncontrolled brady- or tachyarrhythmia - Severe uncorrected valvular heart disease - Paroxysmal atrial fibrillation - Clinically significant concomitant disease states (e.g. hypertension grades 2-3 (>160/100 mmHg), severe renal failure (GFR <30 ml/min/1.73m2), hepatic dysfunction (ALT or AST >3x upper limit of normal, chronic obstructive pulmonary disease (COPD) grades III-IV) - On-going cancer treatment - Significant musculoskeletal disease limiting exercise tolerance - Active infection - Immunosuppressive medical therapy - Earlier hypersensitivity to parenteral iron preparation - Anemia and iron deficiency due to active and/or chronic bleeding - Blood transfusion within the previous 30 days - Red cell, folate and vitamin B12 deficiency - Known or suspected non-compliance, drug or alcohol abuse - Inability to follow the procedures of the study, e.g. due to insufficient language skills, psychological disorders, dementia, etc. - Participation in another intervention study - Enrolment of the investigators, their family members, and other persons involved in the study procedures - Hemoglobin < 120 ng/ml in male patients or < 110 ng/ml in female patients |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hosptal, Baselland | Clinical Trial Unit, University Hospital Basel, Switzerland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in peak oxygen uptake (VO2peak) | Change of VO2peak will be measured by spiroergometry at the baseline and post-intervention visit. | 12 weeks | |
Secondary | Change in ventriculo-arterial coupling (VAC) | VAC is defined as the ratio of arterial elastance (Ea) and end-systolic elastance (Ees) and will be approximated echocardiographically based on the method described by Antonini-Canterin et al. | 12 weeks | |
Secondary | Change in arteriovenous oxygen difference (Da-vO2) | Da-vO2 will be calculated using the Fick Principle | 12 weeks | |
Secondary | Change in pulse wave velocity (PWV) | PWV will be measured at the same time as the echocardiographic parameters with the VaSera VS-2000 Vascular Screening System (Fukuda Denshi Co. Ltd, Tokyo, Japan) and evaluated by experienced blinded members of the study team. | 12 weeks | |
Secondary | Change in New York Heart Association (NYHA) functional class | NYHA functional class will be determined according to the New York Heart Association classification. | 12 weeks | |
Secondary | Change in habitual physical activity | Habitual physical activity will be measured by an accelerometer over a period of 14 consecutive days for 24 hours per day following baseline and post-intervention visits. Patients will wear a waterproof micro-electromechanical triaxial activity bracelet on the non-dominant wrist (GeneActiv, Activinsights Ltd, Kimbolton, Cambridgeshire, UK) to assess physical activity intensity (light, moderate, vigorous) and periods of inactivity, sleep and wake. | 12 weeks | |
Secondary | Change in body composition measured by body mass index (BMI) | BMI will be calculated from measured height in meters and weight in kilograms. Weight and height will be combined to report BMI in kg/m^2. | 12 weeks | |
Secondary | Change in baseline body composition measured by waist to hip ratio (WHR) | WHR will be calculated from measured waist circumference (WC) and hip circumference (HC) in centimetres. WC will be divided by HC to report WHR. | 12 weeks | |
Secondary | Change in total hemoglobin mass (tHb-mass) | tHB-mass will be measured with the carbon monoxide (CO)-rebreathing method | 12 weeks | |
Secondary | Change in quality of life (QoL) by the 36-Item Short Form Health Survey (SF-36) | The SF-36 consists of 36 items, which are formatted as binary questions or as semantic 6-point differential scales. It refers to the past 4 weeks and includes 9 content areas concerning vitality, general health perception, physical functioning, social functioning, role limitations (emotional/physical problems), pain, mental health and health change. | 12 weeks | |
Secondary | Change in baseline quality of life (QoL) by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 weeks. | The KCCQ consists of 15 items concerning overall symptoms, emotional, social and mental status within the past 2 weeks. | 12 weeks | |
Secondary | Change in quality of life (QoL) by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ) at 12 weeks. | The MLWHFQ refers to the past 4 weeks and includes 21 questions on a 6-point scale with a maximum of 105 points (<24 good QoL, >45 poor QoL). | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04949165 -
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
|
N/A | |
Terminated |
NCT03218384 -
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
|
Phase 2 | |
Active, not recruiting |
NCT03516734 -
Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh
|
N/A | |
Completed |
NCT03572010 -
Stable Iron Isotope Method in HIV+ and HIV- Children
|
N/A | |
Active, not recruiting |
NCT03703726 -
Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Not yet recruiting |
NCT05395468 -
Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
|
||
Withdrawn |
NCT03800446 -
Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
|
N/A | |
Not yet recruiting |
NCT03353662 -
Sub Regional Micronutrient Survey in Ethiopia
|
||
Completed |
NCT03819530 -
Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study
|
N/A | |
Recruiting |
NCT04144790 -
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
|
||
Completed |
NCT03957057 -
Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia
|
Phase 3 | |
Completed |
NCT03642223 -
Central and Peripheral Adiposity and Iron Absorption
|
N/A | |
Not yet recruiting |
NCT05407987 -
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
|
Phase 3 | |
Withdrawn |
NCT03873584 -
Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
|
||
Enrolling by invitation |
NCT03897673 -
Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
|
N/A | |
Completed |
NCT04359368 -
Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
|
||
Active, not recruiting |
NCT04778072 -
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
|
N/A | |
Enrolling by invitation |
NCT05750940 -
Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
|
||
Recruiting |
NCT05126901 -
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
|
Phase 3 |