reverse hfpef: ketogenic reversal of heart failure with preserved ejection fraction study

Conditions: Heart Failure

Summary: this protocol is a prospective pilot study utilizing the intervention of a medically supervised, registered nurse and registered diabetes educator coached low-carbohydrate, ketogenic diet to examine the impact it has as a treatment for heart failure with preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * adults (age 21-80) who meet clinical signs and symptoms of heart failure based on clinical assessment. * the subject must meet at least one of the following hemodynamic criteria for hfpef of ph-hfpef by right heart catheterization (rhc) within 6 months of screening visit; a) hfpef: 1. at rest: mean pulmonary artery occlusions pressure (paop) \> 15, pulmonary vascular resistance (pvr) \< 3 wood units, or 2. hfpef with fluid challenge, defined as increase in paop post 500 cc fluid bolus: mean paop \> 18, pvr \< 3 wood units, or 3. hfpef with exercise, defined as peak mean paop \> 17, pvr \ 19 and pvr \ = 50 b) ph-hfpef: 1. at rest: mean pulmonary artery occlusion pressure (paop) \> 15, mean pulmonary artery pressure (pap) \>= 25, pulmonary vascular resistance (pvr) \> 3 wood units, or 2. ph-hfpef with fluid challenge, defined as increase in paop post 500 cc fluid bolus: mean paop \> 18, mean pap \>= 25, pvr \> 3 wood units, or 3. ph-hfpef with exercise, defined as peak mean paop \> 17, peak mean pap \> 30, peak pvr \> 1.34 wood units if age \ 19, peak mean pap \> 33, and pvr \ = 50 * the subject also must meet criteria for metabolic syndrome, defined as: abdominal obesity (bmi \> 30 kg/m2 or abdominal obesity, waist circumference \> 102 cm men, \> 88 cm women) and 2 of the following; a. currently being treated for systemic hypertension or blood pressure (bp) \>= 135/85 b. glucose intolerance with diagnosis of type 2 diabetes, or fasting blood glucose 110-125 mg/dl or hemoglobin a1c \> 6% c. triglycerides \>= 150, or on treatment for high triglycerides d. hdl \< 40 men, \< 50 women, or on treatment for high triglycerides * if the subject is on pulmonary hypertension specific vasodilators, they must be on stable medical therapy without changes to pulmonary vasodilator medication within 3 months prior to screening visit. * the subject must have also had a cardiopulmonary exercise test within 6 months of screening visit. * the subject must have also had an echocardiogram within 6 months of screening visit. * the subject must have demonstrated stable weight (less that 5% weight loss) 3 months prior to screening visit. (they cannot already be losing weight). * the subject owns and uses a smartphone or tablet. * must speak english exclusion criteria: * the subject is already on a significant weight loss trajectory prior to study entry. * the subject cannot be on an alternative diet plan or strategy (e.g., weight watchers, nutrisystem, ornish). * left ventricular ejection fraction \< 50%. * severe valvular disease by echocardiogram or dysfunctional prosthetic valve. * active pericardial disease (moderate or large pericardial effusion or constrictive pericarditis). * active coronary ischemia defined by abnormal stress test, angiogram, or coronary ct angiography per investigator. * prolonged corrected qt interval (qtc) \> 450 ms * significant lung disease on pulmonary function tests (pft's) within the 6 months of screening visit, (both post-bronchodilator values and pre-bronchodilator values must meet exclusion criteria. if either post- or pre-bronchodilator values do not, the subject may be included) defined as either: 1. irreversible obstructive airways disease (post-bronchodilator forced expiratory volume/forced vital capacity (fev1/fvc) \< 70% predicted) or 2. restrictive lung disease (fvc \ = 70%, it is acceptable to have an fvc of \< 70%) or 3. more than mild radiographic pulmonary disease as determine don ct scan within the past 2 years per investigator. * history of non-adherence to diuretics within 3 months of screening visit. * history or recurrent severe hypokalemia, potassium \< 3.0 mg/dl. * history of kidney stones, gout, or gallbladder disease unless in the opinion of the investigator it will not impact the safety of the patient * c-peptide \< 0.5 ng/ml (increased risk of diabetic ketoacidosis (dka)) * uncorrected anemia (hemoglobin \< 10 g/dl). * unable to participate in the comprehensive ketogenic diet program, including biometric data acquisition and data entry (glucometer self-stick and smartphone use). * unable or unwilling to prepare meals for self. * unable to perform quantitative cardia testing regimen (cardiopulmonary exercise testing, 6-minute walk). * subject is pregnant or planning to become pregnant in the next 14 months.

Keywords: obese keto diet cardiac