Treatment for Mitral Valve Insufficiency

1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
+1 More
Eligibility
18+
All Sexes
Eligible conditions
Mitral Valve Insufficiency

Study Summary

Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using Carbon 11(C-11) Acetate Cardiac Positron Emission Tomography Magnetic Resonance Imaging (PET-MRI)

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Eligible Conditions

  • Mitral Valve Insufficiency
  • Valve Regurgitation, Mitral

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Mitral Valve Insufficiency. Measurement will happen over the course of 0-48 hours.

0-48 hours
Quantitatively correlate metabolic findings from the PET component with quantitative T1 and T2 parametric mapping from the cardiac MR component of the hybrid PET-MR study.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

chronic compensated moderate-severe primary mitral regurgitation (PMR)

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

chronic compensated moderate-severe primary mitral regurgitation (PMR)
Drug
Healthy Volunteers
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-48 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0-48 hours for reporting.

Who is running the study

Principal Investigator
P. B.
Prof. Pradeep Bhambhvani, MD
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least 18 years of age.
Patients with chronic, asymptomatic, compensated PMR evaluated in the UAB Structural Valve Clinic OR Normal controls identified from a normal aged matched population.
Negative urine or serum β-human chorionic gonadotropin (hcg) test within 48 hours of [11C] acetate administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Patient Q&A Section

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Other questions from users

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

There is not cost involved in participating in this trial, so insurance won't be necessary.

See if you qualify for this trial
Get access to this novel treatment for Mitral Valve Insufficiency by sharing your contact details with the study coordinator.