Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

Exclusion Criteria

• •1. Patients with a diagnosis of infiltrative cardiomyopathy,
• •2. Presence of severe valvular heart disease,
• •3. Presence of active infection within the 3 months prior to enrollment needing antibiotics (excluding COVID (Coronavirus disease)-19),
• •4. Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to enrollment,
• •5. Known or clinically judged significant (i.e., angina with CCS (Canadian Cardiovascular Society) class \> 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction, percutaneous intervention, or coronary artery bypass grafting),
• •6. History of hypersensitivity to colchicine,
• •7. Evidence of hepatic disease as determined by any 1 of the following: AST or ALT values exceeding 3× the upper limit of normal at enrollment; or patient with a history of cirrhosis, chronic active hepatitis, or severe hepatic disease,
• •8. Patients with estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at enrollment,
• •9. Subject with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea,
• •10. Patient with pre-existent progressive neuromuscular disease,
• •11. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment,
• •12. Patients under long-term steroid medication for a chronic condition,
• •13. Contraindication to dipyridamole-containing medication, acute myocardial infarction or unstable angina in the past 48h,
• •14. Positive pregnancy test results at the screening visit, and females of childbearing potential who do not agree to use adequate methods of contraception for the duration of the study; acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner,
• •15. History or presence of any other disease with a life expectancy of \<1 year,
• •16. Patient considered by the investigator, for any reason, to be an unsuitable candidate for the study.