What side effects are associated with this type of intervention?

Treatments for Long QT Syndrome, particularly those involving glucocorticoids like prednisone, are associated with several side effects. These include hyperglycemia, increased risk of infections, bone loss and fractures, neuropsychiatric effects, and cardiovascular issues such as bradycardia. These side effects necessitate careful monitoring and management during treatment.

What prior FDA approvals exist?

There is no specific information provided about FDA approvals for the treatment of Long QT Syndrome or related drugs in the context. Generally, Long QT Syndrome is managed with beta-blockers like propranolol or nadolol, which are FDA-approved for this condition. Anti-inflammatory drugs like Prednisone are not typically used for Long QT Syndrome, but they may be studied for their potential effects on QT prolongation in specific contexts, such as in patients with connective tissue diseases.

What other types of research exist?

A promising novel alternative to Prednisone for Long QT Syndrome patients is targeting the alternative complement system, which aims to minimize the adverse effects of glucocorticoids while maintaining efficacy and safety. This approach is part of a trend to reduce glucocorticoid use without sacrificing treatment outcomes.

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Corticosteroid

Prednisone for Long QT Syndrome

Phase 4

Waitlist Available

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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 14 days

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

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

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.