The Ketogenic Heart Failure Trial
- Conditions
- Heart failure with reduced ejection fractionCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12624000058572
- Lead Sponsor
- The University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method