NCT04942548已完成不适用
Reverse HFpEF: Ketogenic Reversal of Heart Failure With Preserved Ejection Fraction Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- MLHFQ Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •At rest: mean pulmonary artery occlusions pressure (PAOP) > 15, pulmonary vascular resistance (PVR) < 3 Wood Units, or
- •HFpEF with fluid challenge, defined as increase in PAOP post 500 cc fluid bolus: mean PAOP > 18, PVR < 3 Wood Units, or
- •HFpEF with exercise, defined as peak mean PAOP > 17, PVR < 3 Wood Units if age < 50 or peak mean PAOP > 19 and PVR < 3 Wood Units if age >= 50
- •B) PH-HFpEF:
- •At rest: mean pulmonary artery occlusion pressure (PAOP) > 15, mean pulmonary artery pressure (PAP) >= 25, pulmonary vascular resistance (PVR) > 3 Wood Units, or
- •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
- •PH-HFpEF with exercise, defined as peak mean PAOP > 17, peak mean PAP > 30, peak PVR > 1.34 Wood Units if age < 50 or peak mean PAOP > 19, peak mean PAP > 33, and PVR < 2.1 Wood Units if age >= 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
排除标准
- •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:
- •Irreversible obstructive airways disease (post-bronchodilator forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% predicted) or
- •Restrictive lung disease (FVC < 70% predicted. If total lung capacity (TLC) is >= 70%, it is acceptable to have an FVC of < 70%) or
- •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.
结局指标
主要结局
MLHFQ Questionnaire
时间窗: 6 Months
Change in score on the Minnesota Living with Heart Failure Quality of Life (MLHFQ) Questionnaire for the HFpEF cohort. * Max. Score = 105 * Min. Score = 0 * A reduced score means improvement of heart failure symptoms; better outcome
PAH-SYMPACT Questionnaire
时间窗: 6 Months
Change in score on the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire for the PH-HFpEF cohort. * Max. Score = 89 * Min. Score = 0 * A reduced score means improvement of pulmonary hypertension heart failure symptoms; better outcome
次要结局
- Change in Metabolic Health: Aspartate Aminotransferase (AST)(6 Months)
- Change in Metabolic Health: Triglycerides(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Pressure (PAP)(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Occlusive Pressure (PAOP)(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Cardiac Index (CI)(6 Months)
- Change in Metabolic Health: Insulin(6 Months)
- Change in Metabolic Health: Alanine Transaminase (ALT)(6 Months)
- Change in Metabolic Health: Bilirubin total(6 Months)
- Change in Metabolic Health: High Sensitivity C-Reactive Protein (HS-CRP)(6 Months)
- Change in Metabolic Health: Hemoglobin A1c(6 Months)
- Change in Metabolic Health: Body Mass Index (BMI)(6 Months)
- Changes in Physical Function: Maximum Oxygen Consumption (VO2max)(6 Months)
- Changes in Physical Function: 30 Second Sit-to-Stand test (30s STS)(6 Months)
- Changes in Physical Function: Leg Press - 1 Repetition Maximum(6 Months)
- Changes in Physical Function: Chest Press - 1 Repetition Maximum(6 Months)
- Change in Metabolic Health: Weight(6 Months)
- Change in Metabolic Health: Glucose(6 Months)
- Change in Metabolic Health: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(6 Months)
- Change in Metabolic Health: Albumin(6 Months)
- Change in Metabolic Health: Alkaline Phosphatase (ALP)(6 Months)
- Change in Metabolic Health: High Density Lipoprotein (HDL)(6 Months)
- Changes in Physical Function: Maximum Work(6 Months)
- Changes in Physical Function: 6 Minute Walk Test (6MWT)(6 Months)
- Changes in Physical Function: Leg Extension - 1 Repetition Maximum(6 Months)
- Cardiac Remodeling: Changes in estimated Right Atrial Pressure (RAP)(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Right Atrial Pressure (RAP)(6 Months)
- Cardiac Remodeling: Changes in the Left Ventricle (LV) thickness(6 Months)
- Changes in the rate of mitral annulus velocity (e')(6 Months)
- Changes in the ratio of transmitral early peak velocity (E) by pulsed wave Doppler over e' (E/e')(6 Months)
- Cardiac Remodeling: Changes in the Left Ventricle (LV) size(6 Months)
- Cardiac Remodeling: Changes in the Left Ventricle (LV) mass(6 Months)
- Cardiac Remodeling: Changes in Left Atrium (LA) size(6 Months)
- Cardiac Remodeling: Changes in Inferior Vena Cava (IVC) size(6 Months)
- Cardiac Remodeling: Changes in Right Ventricle Systolic Pressure (RVSP)(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Pulmonary Vascular Resistance (PVR)(6 Months)
- PH-HFpEF Only Hemodynamics: Changes in Cardiac Output (CO)(6 Months)
研究者
Darlene Kim
Associate Professor
National Jewish Health
研究点 (4)
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