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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 14 days
Awards & highlights

Study Summary

This trial aims to find out if there's a connection between anti-Ro/SSA antibodies and an acquired prolongation of the QT interval in people with connective tissue disease.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Corrected QT Interval
Secondary outcome measures
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%
Hypoglycemia
8%
Dysphagia-esophageal radiation
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
~2370

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
14,429 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age threshold for inclusion in this experiment?

"To be eligible for this clinical study, participants must between 18 and 89 years old."

Answered by AI

Is it feasible for me to join this research initiative?

"Those with rheumatoid arthritis between the ages of eighteen and eighty-nine can be accepted into this medical experiment, which is looking to enrol 25 individuals."

Answered by AI

Has the FDA sanctioned Prednisone for clinical use?

"Given the Phase 4 status of this treatment, our internal team at Power has assigned Prednisone a safety rating of 3. This implies that there is an abundance of data supporting its effectiveness and efficacy."

Answered by AI

What conditions commonly respond to Prednisone treatment?

"Prednisone is regularly used to treat thyroiditis and other medical complications like varicella-zoster virus acute retinal necrosis, malignant neoplasms, and ulcerative colitis."

Answered by AI

What research has been conducted in regard to Prednisone's efficacy?

"At the moment, 334 Prednisone clinical trials are in progress and 92 of them have reached Phase 3. While there is a notable concentration of research sites located in Duarte, California, 16404 different locations globally are participating in these studies."

Answered by AI

Is this research currently seeking participants?

"Affirmative, the details on clinicaltrials.gov indicate that this trial is currently recruiting participants. This study was initially posted on September 28th 2011 and was updated most recently on April 7th 2022; it aims to include 25 individuals at a solitary centre."

Answered by AI

How many subjects are partaking in this experiment?

"Affirmative, according to the details posted on clinicaltrials.gov this research study is open for enrollment. The initial posting was made on September 28th 2011 and has been updated as recently as April 7th 2022. 25 participants are needed from 1 centre in total."

Answered by AI
~2 spots leftby Apr 2025