Heart Disease Trial, Recruiting NCT05839730 Sponsor: Medtronic Cardiac Rhythm and Heart Failure Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT05839730
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with heart failure where the heart's pumping function is relatively preserved (the left side of the heart squeezes out at least 55% of its blood with each beat), confirmed by a test done within the last year.
  • People whose heart failure symptoms fall within a mild-to-moderate range, rated as Class I, II, or III on a standard medical scale (meaning symptoms range from none during everyday activity up to being comfortable only at rest).
  • People who have been on a stable, guideline-recommended heart failure medication plan for at least one month (water/fluid pills may be an exception), including consideration of a class of medication called SGLT2 inhibitors.
  • People whose heart's end-of-fill volume (how much blood is in the heart just before it pumps), adjusted for body size, is within a specific range measured by imaging.
  • People whose heart shows a particular structural pattern — either thickened walls or an increased ratio of wall thickness to chamber size — confirmed by at least one specific heart imaging measurement (confirm exact measurements with trial site).

Who may not be able to join:

  • People who are unable or unwilling to have a contrast MRI scan.
  • People who have a standard medical indication for a permanent pacemaker, unless the reason is a specific condition where the heart does not speed up appropriately during exercise.
  • People who currently have a persistent or permanent irregular heart rhythm called atrial fibrillation.
  • People who have a heart structural problem that needs a medical procedure to fix it.
  • People who had a heart valve replacement procedure less than 12 months before joining the trial.
  • People with known stiffening around the heart sac, an inherited condition causing heart muscle thickening, or a disease where abnormal material builds up in the heart muscle.
  • People with severe disease of the aortic or mitral heart valve (either significant leaking or a very narrowed valve opening).
  • People who experience chest pain (angina) during physical activity.
  • People with severe lung disease, including severe COPD — for example, those who need home oxygen, ongoing nebuliser treatment, long-term oral steroid treatment, or who were hospitalised for a lung-related flare-up within the past 12 months.
  • People whose kidneys are functioning below a specific level, measured by a standard formula used to estimate kidney filtration rate.
  • People whose blood pressure is not well controlled and falls outside the range of 100 to 160 mmHg (top number) even while taking blood pressure medication.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 763-526-2817

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Registry
ClinicalTrials.gov
Start date
11 September 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits.; Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.; Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov