A Study to Compare Non-Invasive Venous Waveform Analysis (NIVA) with Total Blood Volume (TBV) in Patients Admitted to the Hospital with Acute Decompensated Heart Failure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010123
Sponsor Protocol Number: 18-010123
About this study
The primary purpose of this study is to evaluate the correlation between Non-Invasive Venous Waveform Analysis (NIVA) score and Total Blood Volume (TBV) in Heart Failure (HF) patients on admission for decompensation and at discharge after diuresis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, greater than or equal to 18 years of age.
- Clinical diagnosis of heart failure with volume overload requiring admission to the hospital for diuresis.
Exclusion Criteria:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Severe cardiac valvular disease;
- Restrictive cardiomyopathy (amyloidosis, ericarditis/effusion);
- Receiving intravenous: epoprostenol, milrinone, dobutamine, dopamine;
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices extracorporeal membrane oxygenation);
- Congenital heart disease;
- Carries the diagnosis of superior vena cava(SVC) syndrome;
- Active infection or sepsis;
- Pregnant or lactating;
- Patients currently (or within 30 days) participating in clinical trial with nvestigational drug or device;
- Known psychiatric or neurologic disease or prisoners who are unable to consent;
- Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Wayne Miller, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available