Phase 2 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have moderate heart failure symptoms that limit activity somewhat, but who are still able to do some physical activity (known as NYHA Class II or III).
• People whose heart is pumping with at least 50% of its normal pumping strength (measured by an echocardiogram).
• People whose heart condition has been stable for at least 2 weeks, based on the doctor's assessment.
• People who have current or past signs that their heart has had increased pressure building up inside it, shown by at least one of: certain measurements on a heart ultrasound; a large left chamber of the heart; long-term use of water tablets to manage symptoms; elevated heart-related protein levels in a blood test within the past year; pressure measurements taken during a heart procedure; or a previous hospital admission for heart failure requiring fluid-removing medication given through a drip.

Who may not be able to join:

• People under 18 years of age.
• People who are pregnant (women who could become pregnant will be given a urine pregnancy test during screening).
• People who are taking certain medications for chest pain (organic nitrates) or certain other medications (phosphodiesterase inhibitors) that cannot be safely stopped during the trial.
• People with an irregular heart rhythm (atrial fibrillation) that is not well controlled, where the resting heart rate is above 100 beats per minute at the time of assessment.
• People with low red blood cell levels (haemoglobin below 10 g/dL).
• People who are unable or unwilling to exercise.
• People with moderate or severe disease of the valves on the left side of the heart, any narrowing of the mitral valve, or severe disease of the valves on the right side of the heart.
• People with a known specific type of heart muscle disease caused by thickening, infiltration, or inflammation of the heart muscle.
• People with a significant disease of the lining around the heart, based on the doctor's assessment.
• People currently experiencing chest pain caused by a significant blockage in the heart's main arteries, based on the doctor's assessment.
• People who have had a heart attack or a procedure to open blocked heart arteries within the past 2 months.
• People with a specific type of high blood pressure in the lungs not caused by heart failure (WHO Group 1 Pulmonary Arterial Hypertension).
• People with significant lung disease, including advanced chronic obstructive pulmonary disease, use of steroid tablets for a lung flare-up in the past 6 months, or current use of supplemental oxygen (except overnight oxygen for sleep apnoea). Low blood oxygen levels during an exercise test would also make someone ineligible.
• People who have shown significant signs of reduced blood flow to the heart during a stress test, without having had a procedure to fix it, a scan confirming no major blockages, or a follow-up stress test with a clear result. Abnormal heart wall movement during an exercise echocardiogram test would also make someone ineligible.
• People whose heart pumping strength was measured below 45% on a previous heart scan, unless this was caused by a temporary irregular heart rhythm that has since been treated and the pumping strength has returned to normal.
• People with significant liver disease affecting how the liver works, based on abnormal liver blood test results or low protein levels in the blood.
• People with significantly reduced kidney function (eGFR below 30 mL/min/1.73m²).
• People with a blood condition where a substance called methemoglobin is above 5%.
• People with a high potassium level in the blood (above 5.0 mEq/L) at the time of baseline testing.
• People with Type 1 Diabetes.
• People with a history of a condition called ketoacidosis.
• People who are currently taking, or who have previously not tolerated, a type of diabetes medication called an SGLT2 inhibitor.
• People who are currently following a ketogenic (very low carbohydrate, high fat) diet.
• People with an allergy to beetroot.
• People with severe dysfunction of the right side of the heart.
• People with a resting seated blood pressure that is either too high (above 180 mmHg systolic) or too low (below 100 mmHg systolic).
• People who have consistently low or high blood pressure at rest, or whose blood pressure drops significantly when standing up (a drop of more than 20 mmHg, or a fall below 90 mmHg, within 2–3 minutes of standing), measured at the baseline visit.
• People who are currently taking part in another clinical trial involving an experimental treatment (participation in observation-only studies or registries is generally permitted — confirm with trial site).
• People with any other condition that, in the opinion of the trial doctor, could interfere with completing the study, including other health conditions, mental health conditions, or practical barriers such as difficulty travelling to the exercise facility.

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