Last updated: July 14, 2022
Sponsor: University of Aarhus
Overall Status: Active - Recruiting
Phase
1
Condition
Heart Failure
Hyponatremia
Congestive Heart Failure
Treatment
N/AClinical Study ID
NCT04442555
KETO-AHF1 1-10-72-59-19
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Hospitalized with worsening HF or de novo diagnosis of HF
- LVEF < 50%
- Treatment with intravenous loop diuretics during the hospitalization and/or increaseddosage of oral diuretics.
Exclusion
Exclusion Criteria:
- Cardiogenic shock
- Systolic Blood Pressure <85 mmHg
- Acute myocardial infarction other than type II <5 days prior to randomization *
- Severe uncorrected cardiac valve disease
- Expected or possible need for hemodialysis as judged by the investigator
- Ongoing inotropic treatment
- Possible need for advanced heart failure treatment (LVAD, heart transplantation) asjudged by the investigator.
- Ongoing, severe infection
- Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/minor intubated)
- Atrial Fibrillation with heart >120 beats per minute
- Inability to cooperate to or accept oral intake of food, including presence of majorgastrointestinal discomfort.
- If suspected or confirmed acute myocardial infarction as cause of acute heartfailure, patients can be recruited 5 days after hospitalization in the absence ofmalignant arrhythmias (e.g. ventricular tachycardia) or clinically significantresidual angina pectoris.
Study Design
Total Participants: 12
Study Start date:
February 01, 2020
Estimated Completion Date:
March 30, 2023
Connect with a study center
Aarhus University Hospital
Aarhus, 8200
DenmarkActive - Recruiting
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