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Corticosteroid

Prednisone for Long QT Syndrome

Phase 4
Recruiting
Research Sponsored by Narrows Institute for Biomedical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Atrial fibrillation
Known diagnosis or family history of hereditary Long QT syndrome, complete bundle brunch block, ventricular paced rhythm, profound bradycardia and tachycardia, and uncorrected hypothyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 14 days
Awards & highlights

Summary

This trial aims to see if prednisone can help patients with connective tissue disease who have a heart rhythm issue. Prednisone is used to reduce inflammation and immune activity, which might improve heart rhythm. Prednisone is a glucocorticoid commonly used to reduce inflammation and immune activity in various conditions, including connective tissue diseases.

Who is the study for?
This trial is for patients with connective tissue disease treated at New York Harbor Healthcare System. It's not for those with heart rhythm problems, acute conditions, drug overdose, extreme body temperature issues, hereditary Long QT syndrome, severe slow or fast heartbeat, or untreated thyroid issues.
What is being tested?
The study aims to see if anti-Ro/SSA antibodies cause longer heartbeats in people with connective tissue diseases and if this can be reversed using moderate doses of prednisone in cases where the heartbeat interval exceeds 500 milliseconds.
What are the potential side effects?
Prednisone may cause side effects such as increased appetite, mood changes, high blood pressure, fluid retention leading to swelling in your lower legs and an increase in blood sugar levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have atrial fibrillation.
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I have or my family has a history of heart rhythm problems or untreated thyroid issues.
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I have a lower than normal body temperature.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Corrected QT Interval
Secondary study objectives
Change in CRP
Change in Cytokine Levels
Change in ESR

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prednisone GroupExperimental Treatment1 Intervention
These patients have CTD and QTc over 500 msec. Prednisone is administered as a preventative measure against arrhythmia via QTc shortening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Long QT Syndrome (LQTS) treatments focus on preventing arrhythmias and sudden cardiac events by normalizing the heart's electrical activity. Prednisone, an anti-inflammatory corticosteroid, is being studied for its potential to reverse QT prolongation by reducing inflammatory cytokines that may contribute to the condition. This approach could be particularly beneficial for LQTS patients where inflammation is a contributing factor, offering a new avenue for managing the syndrome.
[A case of "syndrome of progressive muscle spasm, alopecia, and diarrhea (Satoyoshi)" treated with steroid pulse therapy].ECG abnormalities in polymyositis.Effects of timing of methylprednisolone or naloxone administration on recovery of segmental and long-tract neurological function in NASCIS 2.

Find a Location

Who is running the clinical trial?

Narrows Institute for Biomedical ResearchLead Sponsor
4 Previous Clinical Trials
629 Total Patients Enrolled
VA New York Harbor Healthcare SystemFED
24 Previous Clinical Trials
14,420 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04169100 — Phase 4
Long QT Syndrome Research Study Groups: Prednisone Group
Long QT Syndrome Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT04169100 — Phase 4
Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169100 — Phase 4
~2 spots leftby Oct 2025