Ketogenic Diet in Heart Failure with Reduced Ejection Fraction: A Pilot Randomised Controlled Trial (The KETO-HF Trial)

The University of Sydney0 个研究点目标入组 60 人开始时间: 2024年1月25日最近更新: 2024年2月5日

适应症

试验速览

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•1. Age 18 years and older
•2. HFrEF with a LVEF less than or equal to 40%
•3. Willingness to try and adhere to a dietary intervention and to be randomised.
•4. At least one enrolment enhancing criteria:
•a. N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP), pro-BNP =600 pg/mm in the preceding 12 months
•b. Hospital admission for heart failure in the preceding 12 months (including admission at the time of diagnosis)
•c. Current heart failure symptoms: NYHA Class II, III or IV
•d. Type 2 Diabetes mellitus
•e. Renal impairment eGFR<45ml/min

•1. Type 1 Diabetes Mellitus or Type II Diabetes Mellitus requiring insulin.
•2. Women who are pregnant, breastfeeding or planning a pregnancy during the study period
•3. Symptomatic hypotension or systolic blood pressure <90mmHg
•4. Body mass index (BMI) <18.5 kg/m2
•5. History of rare metabolic conditions:
•a. Insulinoma
•b. Primary carnitine deficiency
•c. Carnitine palmitoyl transferase I or II deficiency
•d. Carnitine translocase deficiency
•e. Beta-oxidation defects
•f. Medium-chain acyl dehydrogenase deficiency
•g. Long-chain acyl dehydrogenase deficiency
•h. Short-chain acyl dehydrogenase deficiency
•i. Long-chain 3-hydroxyacyl-CoA deficiency
•j. Medium-chain 3-hydroxyacyl-CoA deficiency
•k. Pyruvate carboxylase deficiency
•l. Porphyria
•6. Non-English-speaking participants can be included if they are amenable to undergo the intervention and follow-up with the assistance of an interpreter.

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