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临床试验/NCT04235699
NCT04235699终止不适用

Benefits of Ketogenic Diet in Patients With Heart Failure With Preserved Ejection Fraction: A Pilot Study

Ohio State University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Changes in maximal exercise performance

研究概览

简要总结

This study is being done to evaluate the effects of a low carbohydrate ketogenic diet on exercise tolerance in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), also known as Diastolic Heart Failure (DHF).

详细描述

Patients will be randomized to either a ketogenic diet, or a low-fat diet higher in carbohydrate and based on current dietary guidelines. Regardless of what group you are randomized to, you will consume the diet for a period of 4 weeks. All foods will be prepared by our research group and provided to you. Both diets will be based on an approximately 25% reduction in your dietary caloric requirements, so some weight loss may occur over the 4-week intervention.

Primary data collection will occur at baseline and at four weeks, with more frequent monitoring of blood markers, blood pressure, heart rate, and overall health. Throughout the duration of the study, you will be continued on standard heart failure therapies as guided by your treating physician. The duration of the study is expected to last for approximately 6 weeks. This includes all before and after testing, as well as the 4 weeks on diet.

All patients will undergo a resting MRI scan of the heart at enrollment (baseline), and again at the end of the 4-week diet. You will not receive any injections.

All participants will also undergo a cardiopulmonary stress test (CPET, also known as VO2 testing) at enrollment (baseline) and again at the end of the 4-week dietary intervention. During the Cardiopulmonary stress testing you will be asked to exercise on a treadmill while breathing into a mask.

All participants will also undergo body fat and body fluid composition by dual-energy X-ray absorptiometry (DXA) at enrollment (baseline) and again at the end of the 4 week dietary intervention. You will be exposed to a very small amount of radiation by the DXA scanner used to measure your body composition. However, amount of radiation used in DXA is extremely low (by comparison, a standard chest x-ray is 125 times more radiation than a DXA scan).

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old and ≤ 75 years old & willingness to be randomized to either diet
  • Confirmed diagnosis of heart failure with ejection fraction ≥50% (NYHA Class II-IV)
  • On optimal medical therapy for at least 3 months as determined by the treating physician
  • Body Mass Index (BMI) ≥ 25
  • Ability to participate in exercise treadmill testing

排除标准

  • Contraindications to MRI including pregnancy
  • Diagnosis of diabetes mellitus treated with insulin or SGLT2 inhibitors.
  • History of diabetic ketoacidosis
  • Recent (within 30 days) or planned (within 30 days) cardiac revascularization
  • Recent acute myocardial infarction or acute coronary syndrome (30 days)
  • Body Mass Index (BMI) < 25, or BMI > 40
  • Hepatic cirrhosis
  • Use of metformin > 1700 mg daily
  • Left ventricular ejection fractions < 50%
  • Prior diagnosis of moderate to severe COPD
  • Uncontrolled systemic systolic/diastolic hypertension (SBP > 150 mmHg or DBP > 90 mmHg)
  • Echocardiographic evidence of significant valvular disease
  • History of ventricular tachycardia or SCD
  • Untreated moderate or severe sleep apnea

结局指标

主要结局

Changes in maximal exercise performance

时间窗: Baseline and end of study participation, 6 weeks

Participants will undergo VO2 max testing, conducted by trained professionals. VO2 max testing analyses will determine changes in maximal exercise performance

次要结局

  • Change in NYHA class(Baseline and end of study participation, 6 weeks)
  • Change in CMR measures of cardiac function(Baseline and end of study participation, 6 weeks)
  • Change in Quality of Life Questionnaire(Baseline and end of study participation, 6 weeks)
  • Change in Serologic Markers(Baseline and end of study participation, 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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