Biomarker Guided Therapies in Stage A/B Heart Failure

This is an interventional prevention trial for Hypertension focused on measuring heart failure, biomarkers, troponin, BNP, carvedilol, spironolactone, prevention Read More

Inclusion Criteria:

Only Veterans are eligible to participate. Other inclusion criteria include

• Age greater than 40 years
• One of the following in order to establish Stage A HF a. Hypertension b. Diabetes mellitus (controlled: defined as hemoglobin A1c less than 9%) c. Obesity (defined as BMI greater than 30 kg/m2) d. Metabolic syndrome (using the National Cholesterol Education Panel definition) e. Left ventricular hypertrophy (by ECG) f. Coronary or cerebrovascular arterial disease
• Troponin T measured by the high sensitivity assay of greater than 5ng/L
• Systolic BP 120-155 mmHg at primary care provider (PCP) visit and prerandomization visit (i.e., 2 separate confirmations of the same). If there is discordance between the PCP visit and pre-randomization the investigators will bring patient back to recheck his BP and use that as the tie breaker. Not orthostatic with measurements (defined as a fall in systolic BP greater than 20 mmHg when subjects assume an upright position). - Estimated 10-yr HF risk (based on Atherosclerosis Risk in Communities HF Lab model) greater than 5%
• Provides informed consent

Exclusion Criteria:

The exclusion criteria include

• Active Atrial fibrillation
• History of chest/ neck radiation
• High-risk chronic obstructive pulmonary disease (COPD) (GOLD classification 3-4 with greater than equal to 2 COPD exacerbations in the last 12 months)
• Known allergy to carvedilol or spironolactone
• Renal insufficiency with estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min
• Serum potassium greater than 5 meq/L
• Current use of carvedilol, spironolactone, any other beta-blockers or aldosterone antagonists
• Signs of clinical HF on initial examination (pulmonary rales/crackles, elevated jugular venous pulse with S3/S4 on auscultation)
• Left ventricular ejection fraction <50% by echo
• Moderate or greater valve stenosis or regurgitation
• Hypertrophic cardiomyopathy
• Exposure to known cardiotoxic chemotherapy
• Poor echo image quality
• Right ventricular dysfunction more than mild
• Any valvular dysfunction that is more than mild
• Any life-threatening disease expected to result in death within the next 2 years
• Active severe liver disease (evaluated at Visit 1): cirrhosis, active hepatitis, aspartate transaminase (ALT) or alanine transaminase (AST) greater than 3 x ULN, or biliary obstruction with hyperbilirubinemia (total bilirubin greater than 2 x ULN).
• Participation in another clinical trial involving an investigational agent within 90 days prior to randomization
• Any condition or therapy which, in the opinion of the investigator, might pose a risk to the patient or make participation in the study not in the patient s best interest
• Drug or alcohol abuse within the past 6 months, and unable/unwilling to abstain from drug abuse and excessive alcohol consumption during the study. Excessive alcohol consumption is on average greater than 2 units of alcohol per day. A unit of alcohol is defined as a 12-ounce (350 mL) beer, 5-ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80 ]proof alcohol for drinks.
• Mental/psychological impairment or any other reason to expect patient difficulty in complying with the requirements of the study.
• Any immunosuppressed condition where intercurrent illnesses may affect interpretation of study results
• Pregnant women or any woman planning a pregnancy during the study period
• Not meeting any of the inclusion criteria