Assess Measurements of Wireless Cardiac Output Device

NCT02252757 | Completed

• 1 other identifier: AV.CO.v0-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system

Conditions

Congestive Heart Failure

Keywords

mHealth, hypertension, atherosclerotic disease, diabetes, obesity, metabolic syndrome, cardiotoxins, cardiomyopathy, dsypnea

Outcome Measures

Primary Outcomes (1)

• Measuring Cardiac Output for wireless transmission as per discharge guideline

  2 Weeks

Interventions

CoVa DEVICE

Also known as: Vitalbeat Remote Disease Managment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is targeted towards at-risk heart failure patients. An "at-risk" patient is defined as a patient who has risk factors for Heart Failure as described in the table below

You may qualify if:

• Subjects of either gender above the age of 18 years
• The subject is able and willing to provide written informed consent prior to enrollment in the study
• One or more of the following diagnosis
• New York Heart Association (NYHA) classification class of I-IV or Stages A-D
• Symptoms of dyspnea
• Chronic renal failure on renal replacement therapy

You may not qualify if:

• Patients who may not come for follow up or likely to drop out of the study
• Any illness which may preclude regular follow up
• Patient is unable or not willing to wear electrode patches as required
• Patient has skin sensitivity to adhesive or hydrogel materials used in electrode patches
• Patient is considered by the PI to be medically unsuitable for study participation

Sponsors & Collaborators

• Aventyn, Inc.: lead
• Baxter Healthcare Corporation: collaborator
• BMS Hospital Trust: collaborator
• Intel Corporation: collaborator

Study Sites (1)

Scottsdale Cardiovascular Center

Scottsdale, Arizona, 85251, United States

Location

Related Publications (3)

• Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.

  PMID: 17426062 BACKGROUND

• Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.

  PMID: 20687083 BACKGROUND

• Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.

  PMID: 16160202 RESULT

Related Links

• Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)

MeSH Terms

Conditions

Heart Failure; Hypertension; Diabetes Mellitus; Obesity; Metabolic Syndrome; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Study Officials

• Kris Vijay, MD, MS, FACC

  Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

US (1)