Hemodynamic Assessment in Acute Decompensated Heart Failure

Status Completed

Clinical Trial Summary

Clinical Trial Description

This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.

All patients enrolled in the study will first provide written informed consent to participate and then the research coordinator will check that the subject meets all study inclusion criteria and does not meet any of the study exclusion criteria. Enrolled subjects will undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over the course of their hospitalization. There will be at least eight (8) hours between assessment sessions.

Each assessment session includes recording of the subject's weight, measurements with the reference devices, and measurements with the novel optical system. During the session, the subject will be assessed in the supine, sitting, and standing positions. NT-proBNP measurements will be done at the start of study participation and the end. A market research questionnaire will be administered to the subject following the first measurement session. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03535909
Study type	Observational
Source	Rodin Scientific LLC
Contact
Status	Completed
Phase
Start date	June 9, 2018
Completion date	July 31, 2018

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Recruiting	`NCT05562037` - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA	N/A
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed	`NCT04037436` - Functional Exercise and Nutrition Education Program for Older Adults	N/A
Recruiting	`NCT04703842` - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction	Phase 1/Phase 2
Terminated	`NCT05594940` - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting	`NCT04982081` - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection	Phase 1
Completed	`NCT04394754` - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure	N/A
Active, not recruiting	`NCT01385176` - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)	N/A
Not yet recruiting	`NCT05516290` - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Terminated	`NCT02788656` - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)	Phase 4
Completed	`NCT02885636` - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial	Phase 3
Completed	`NCT02252757` - Assess Measurements of Wireless Cardiac Output Device	N/A
Terminated	`NCT02205411` - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation	N/A
Completed	`NCT01362855` - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Withdrawn	`NCT00346177` - Stem Cell Study for Patients With Heart Failure	Phase 2
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Active, not recruiting	`NCT01058837` - SCD-HeFT 10 Year Follow-up	N/A
Completed	`NCT00957541` - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.