NCT04347655 Assessing Systemic Circulation and LV Performance in Adults
| NCT ID | NCT04347655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-09-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background There are significant limitations in the current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. The investigators' have repurposed the concepts of "systemic vascular conductance" to assess systemic circulation, and the "head capacity principle" to assess LV performance. The investigators' now seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods. Hypothesis There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function. Methods The research study will involve a single outpatient visit per subject. The study will take place with the subject supine on a bed/table. The subjects will be instrumented with EKG electrodes and finger blood pressure cuffs. The continuous finger BP device performs a waveform analysis in real-time to determine the non-invasive stroke volume, cardiac output, and blood pressure. The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes. Following the handgrip test, the instrumentation will be removed and the patient's participation in the study will be complete. The study duration should be about 20 min.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Clinical heart failure (HFrEF or HFpEF) for heart failure patients and no clinical heart failure for the non-heart failure participants. Exclusion Criteria: * Unable or unwilling to provide informed consent * On intravenous inotrope or pressor medications to maintain their cardiac function
Contact & Investigator
Satish R Raj, MD MSCI
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT04347655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04347655 currently recruiting?
Yes, NCT04347655 is actively recruiting participants. Contact the research team at autonomic.research@ucalgary.ca for enrollment information.
Where is the NCT04347655 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT04347655 clinical trial?
NCT04347655 is sponsored by University of Calgary. The principal investigator is Satish R Raj, MD MSCI at University of Calgary. The trial plans to enroll 100 participants.
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