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New treatment option for Cardiac Sarcoidosis
Official title Cardiac Sarcoidosis Randomized Trial
ClinicalTrials.gov ID: NCT03593759
What this study is testing
What is Prednisone or Prednisolone?
Prednisone or Prednisolone is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for cardiac sarcoidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:
- advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
- significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
- non- sustained or sustained ventricular arrhythmia
- left ventricular dysfunction (LVEF \< 50%)
You likely can't join if
- Current or recent (within two months) non-topical treatment for sarcoidosis
- Current Oral/IV treatment of duration greater than 5 days
- Currently taking Methotrexate or Prednisone for another health condition
- Intolerance or contra-indication to Methotrexate or Prednisone
- Patient does not meet all of the above listed inclusion criteria
- Patient is unable or unwilling to provide informed consent
See the full eligibility criteria
- (i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:
- advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
- significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
- non- sustained or sustained ventricular arrhythmia
- left ventricular dysfunction (LVEF \< 50%)
- right ventricular dysfunction (RVEF \< 40%) AND (ii) No alternative explanation for clinical features AND (iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of...
- Current or recent (within two months) non-topical treatment for sarcoidosis
- Current Oral/IV treatment of duration greater than 5 days
- Currently taking Methotrexate or Prednisone for another health condition
- Intolerance or contra-indication to Methotrexate or Prednisone
- Patient does not meet all of the above listed inclusion criteria
- Patient is unable or unwilling to provide informed consent
- Patient is included in another assigned by chance clinical trial
- Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
- Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
- Breastfeeding
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Patients for whom the investigator believes that the trial is not in the interest of the patient
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneota, Minnesota, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Minneota, Minnesota, United States; New York, New York, United States; Columbus, Ohio, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.