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ANHYDROUS MANGAFODIPIR TRISODIUM

Clinical trials are investigating ANHYDROUS MANGAFODIPIR TRISODIUM in people with heart failure, especially heart failure with preserved ejection fraction (HFpEF). The study data focus on how it performs in MRI research and whether manganese uptake can be measured in the heart.

Table of Contents

Trial overview

Only one clinical trial was provided for ANHYDROUS MANGAFODIPIR TRISODIUM. It studied the substance in a heart failure setting and used MRI to measure manganese uptake in the heart.[1]

The trial was completed and included 42 participants.[1]

Who was studied

The target population was people with heart failure, especially those with heart failure with preserved ejection fraction (HFpEF).[1]

HFpEF is a type of heart failure where the heart may still pump out blood, but it does not relax and fill normally.[1]

Study design and phase

This was an interventional study, which means researchers gave a study intervention and then measured the effect.[1]

The trial was in Phase 2, a stage that usually looks more closely at how well a study approach works in a specific group of patients.[1]

The intervention list included ANHYDROUS MANGAFODIPIR TRISODIUM given by intravenous administration, along with Dotarem as another imaging-related drug in the study record.[1]

What was measured

The primary endpoint was the determination of the manganese uptake rate.[1]

An endpoint is the main result that researchers plan to measure in a trial.[1]

The brief summary says the study aimed to quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.[1]

Trial details

The trial title describes ANHYDROUS MANGAFODIPIR TRISODIUM as an intracellular contrast agent for Magnetic Resonance Imaging (MRI) in patients with heart failure and preserved ejection fraction.[1]

“Contrast agent” means a substance used in imaging tests to help body parts show up more clearly.[1]

The study status was completed, so the trial record indicates that enrollment and follow-up were finished.[1]

Patient-friendly terms

  • Heart failure: the heart does not pump blood as well as it should.[1]

  • Preserved ejection fraction: the heart still pumps out a normal amount of blood, but it may not fill properly.[1]

  • Left ventricular wall: the muscle wall of the heart’s main pumping chamber.[1]

  • Intravenous administration: giving a substance through a vein.[1]

  • Manganese uptake rate: how much manganese is taken up by the heart tissue over time.[1]

Trial ID Phase Condition studied Status Enrollment
2023-508118-40-01 Phase 2 Heart Failure Completed 42

FAQ

  • What is being studied in the ANHYDROUS MANGAFODIPIR TRISODIUM trial? The trial is studying manganese uptake in the heart after ANHYDROUS MANGAFODIPIR TRISODIUM is given during MRI research. The main goal is to measure the uptake rate in the left ventricular wall.
  • Who was the target population in this trial? The study targeted patients with heart failure, especially those with preserved ejection fraction (HFpEF). This means people whose heart pumps but does not fill normally.
  • What phase was the trial? This was a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment or test works as planned in a specific patient group.
  • What was the main endpoint? The primary endpoint was the determination of the manganese uptake rate. An endpoint is the main result the researchers want to measure.
  • Was the trial completed? Yes, the trial status was completed. It enrolled 42 participants.

Ongoing Clinical Trials on ANHYDROUS MANGAFODIPIR TRISODIUM

  • Study on Manganese Uptake in Heart Failure Patients Using Mangafodipir Trisodium and Gadoteric Acid

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Norway

Glossary

  • Heart failure: A condition where the heart does not pump blood as well as it should.
  • HFpEF: Heart failure with preserved ejection fraction. This means the heart can still pump out a normal amount of blood, but it does not relax and fill properly.
  • Magnetic Resonance Imaging (MRI): A scan that uses magnetic fields to make detailed pictures of the inside of the body.
  • Contrast agent: A substance used in imaging tests to help certain body parts show up more clearly.
  • Intravenous administration: Giving a substance through a vein, usually with a needle or small tube.
  • Interventional study: A study where researchers give a treatment or test to participants and measure the effect.
  • Phase 2: A mid-stage clinical trial that looks more closely at how well a study treatment or test works and continues checking safety.
  • Primary endpoint: The main result researchers plan to measure in a trial.
  • Manganese uptake rate: How much manganese is taken up by the heart tissue over time.
  • Left ventricular wall: The muscle wall of the heart’s main pumping chamber.

References

  1. https://clinicaltrials.gov/study/2023-508118-40-01