Heart & Vascular Clinical Trials
Continuous Lactate Monitoring in Ambulatory Chronic Heart Failure Patients (LAC-HF)
What is the purpose of this study?
The objective of the study is intended to demonstrate the feasibility of the Continuous Lactate Monitoring Biosensor in patients with New York Heart Association (NYHA) Class II, IIIA, IIIB or IV Heart Failure (HF). The relationship between the interstitial fluid lactate sensor data, NYHA assessments, and functional capacity assessed by 6-minute walk test will be evaluated in ambulatory chronic heart failure patients.
Eligibility
1. At least 18 years of age.
2. A diagnosis of heart failure, defined as
a. At least 1 heart failure hospitalization (HFH) within 12 months OR
b. Elevated NTproBNP >800 pg/mL, (if NTproBNP not available, BNP ≥100 pg/mL) within 12 months of enrolment.
3. New York Heart Association Class II, Class IIIA, Class IIIB or Class IV, documented at enrolment.
4. Must be able to follow the instructions provided by the study site and perform all study tasks as specified by the protocol.
5. Must be willing and able to provide written signed and dated informed consent.
6. Subject must have stable living conditions with continuous access to electricity and wireless internet.
7. Must be willing to wear a commercially available activity tracker (e.g., Fitbit) for the entire study period.
8. In the investigator’s opinion, the subject must be able to follow the instructions provided by the study site and perform all study tasks as specified by the protocol, including, but not limited to:
• Wearing an activity tracker (e.g., Fitbit) and CLM sensors for the duration of the study.
• Compliance with sensor replacement schedule by the subject or willingness to travel to the site for sensor replacement by the site staff.
• Compliance with smartphone management including regular charging and returning it to the site at the end of the study
1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial lactate measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection, or oedema.
3. Subject is currently participating in another interventional (pharmacological) clinical trial.
4. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
5. For female participants, subject must not be pregnant or planning to become pregnant during the study period. When appropriate, subjects will be required to undergo a urine pregnancy test to ensure compliance with the exclusion criteria.
Where can I participate?
What is the full name of this Clinical Trial?
Continuous Lactate Monitoring in Ambulatory Chronic Heart Failure Patients (LAC-HF)
- Disease Type/ConditionChronic Heart Failure
- Principal InvestigatorHao A. Tran, MD
- Co-InvestigatorsAndy Y. Lee
- Age GroupAdult
- PhaseN/A
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Jeffrey M. Carlton Heart & Vascular Institute
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute provides advanced, coordinated care for complex heart and vascular conditions, bringing together nationally recognized cardiologists, cardiac surgeons, electrophysiologists, heart failure specialists, and vascular experts. Patients have access to comprehensive evaluation, leading cardiovascular programs, advanced treatment options, and clinical trials designed to help identify the right path forward.
