Cardiac Sarcoidosis Randomized Trial

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ottawa Heart Institute Research Corporation
Study ID
NCT03593759
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Sarcoidosis
  • Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone or Prednisolone — DRUG
    Oral prednisone/prednisolone tablet
  • Methotrexate — DRUG
    Oral, subcutaneous, or intramuscular methotrexate

Study Details

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).

Key Dates

Start date
Jan 15, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Prednisone (or Prednisolone)
    \[Dose everywhere except Japan\] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg) \[Dose in Japan\] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months
  • Experimental: Methotrexate
    \[Dose everywhere except Japan\] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid OD (exact dose and directions at physicians discretion) for 6 months. \[Dose in Japan\] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.

Primary Outcome Measure

Summed perfusion rest score (SPRS) on FDG-PET scan [ Time Frame: 6 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale-New Haven HospitalNew HavenConnecticut06520
Edward Miller, MD
[email protected]
203-737-8871
Edward Miller, MD (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111
Mili Mehta, MD
Amanda Vest, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan-Michigan Medicine Cardiovascular CenterAnn ArborMichigan48109-5853
Todd Koelling, MD
[email protected]
734-936-5265
Todd Koelling, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneotaMinnesota55455
C Shenoy, MD
C Shenoy, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterNew YorkNew York10467
Yogita Rochlani, MD
[email protected]
Yogita Rochlani, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210
Steven Kalbfleisch, MD
[email protected]
Steven Kalbfleisch, MD (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Indu Poornima, MD
[email protected]
Indu Poornima, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Line Kemeyou, MD
[email protected]
Line Kemeyou, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298-0053
Jordana Kron, MD
[email protected]
804-828-7565
Jordana Kron, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale-New Haven Hospital· New Haven, CTTufts Medical Center· Boston, MAUniversity of Michigan-Michigan Medicine Cardiovascular Center· Ann Arbor, MIUniversity of Minnesota· Minneota, MNMontefiore Medical Center· New York, NYThe Ohio State University Wexner Medical Center· Columbus, OH

Related Studies