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Iron Sucrose in Patients With Iron Deficiency and POTS

Primary Purpose

Iron-deficiency, Postural Orthostatic Tachycardia Syndrome

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sucrose

Placebo

Tilt Table Test

About this trial

This is an interventional treatment trial for Iron-deficiency

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
Symptomatic orthostatic heart rate increment ≥30 bpm if >19 years old or ≥40 bpm if <19 years old during a 10 minute 70 degree head up tilt study
Presence of non-anemic iron deficiency, defined as serum ferritin levels <20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
Consent obtained from responsible guardian AND from subjects, 12-17 years of age
Consent obtained for subjects 18 years of age and older

Exclusion Criteria:

Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHg within 3 minutes of 70 degree head up tilt study)
Pregnant or lactating females
The presence of failure of other organ systems or systemic illness that can affect autonomic function
Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
Laboratory evidence of anemia or iron overload
Personal history of hematochromatosis or first degree relative with hematochromatosis
Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iron Sucrose Group

Placebo Group

Arm Description

Subjects will receive intravenous iron sucrose during a tilt table test

Subjects will receive intravenous placebo during a tilt table test

Outcomes

Primary Outcome Measures

Change in autonomic dysfunction symptoms

Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction

Change in postural heart rate increase

Heart rate change during tilt table test measured in beats per minute

Secondary Outcome Measures

Full Information

NCT ID

NCT04855266

First Posted

April 19, 2021

Last Updated

June 12, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04855266

Brief Title

Iron Sucrose in Patients With Iron Deficiency and POTS

Official Title

A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit participants

Study Start Date

April 2021 (Anticipated)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron-deficiency, Postural Orthostatic Tachycardia Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron Sucrose Group

Arm Type

Experimental

Arm Description

Subjects will receive intravenous iron sucrose during a tilt table test

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Subjects will receive intravenous placebo during a tilt table test

Intervention Type

Drug

Intervention Name(s)

Sucrose

Other Intervention Name(s)

Venofer

Intervention Description

5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)

Intervention Type

Diagnostic Test

Intervention Name(s)

Tilt Table Test

Intervention Description

A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.

Primary Outcome Measure Information:

Title

Change in autonomic dysfunction symptoms

Description

Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction

Time Frame

Baseline, 7 days, 6 months

Title

Change in postural heart rate increase

Description

Heart rate change during tilt table test measured in beats per minute

Time Frame

Baseline, 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations. Symptomatic orthostatic heart rate increment ≥30 bpm if >19 years old or ≥40 bpm if <19 years old during a 10 minute 70 degree head up tilt study Presence of non-anemic iron deficiency, defined as serum ferritin levels <20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender Consent obtained from responsible guardian AND from subjects, 12-17 years of age Consent obtained for subjects 18 years of age and older Exclusion Criteria: Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHg within 3 minutes of 70 degree head up tilt study) Pregnant or lactating females The presence of failure of other organ systems or systemic illness that can affect autonomic function Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study Laboratory evidence of anemia or iron overload Personal history of hematochromatosis or first degree relative with hematochromatosis Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamal Shouman, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Iron Sucrose in Patients With Iron Deficiency and POTS

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