Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study

NCT01347567 | Completed

• 1 other identifier: BSTE-0135
• Study Type: interventional
• Target: 145
• Locations: 6 countries
• Sites: 7

Brief Summary

The purpose of this study is to determine if heart failure subjects whose treatment is assisted by home BNP measurements integrated into a home health management system will have better clinical outcomes than subjects whose treatment includes home health management without BNP or than subjects treated by standard care.

Conditions

Heart Failure; Systolic Heart Failure; Acute Decompensated Heart Failure

Keywords

Fingerstick BNP test; Home Health Management System; Acute Decompensated Heart Failure; Hospital Readmission; Prevention

Outcome Measures

Primary Outcomes (1)

• Average number of "hard' events per subject

  With hard events defined as: * HF related death, * HF related readmissions to the hospitaL, * IV treatment with diuretics or unusual oral diuretic change in ER * Unplanned outpatient treatments for decompensated HF

  Over 180 days

Study Arms (3)

BNP + Health Management

EXPERIMENTAL

Subjects will provide information from home regarding weight,signs and symptoms, and will perform BNP self testing. This information including BNP results will be used by the investigator as an aid to treatment decisions. BNP results are blinded to subjects.

Other: Interventions with heart failure medications

Health Management

ACTIVE COMPARATOR

Subjects will provide information from home regarding weight, signs and symptoms, and will perform BNP self testing . BNP results will be blinded to the investigator and subject; weight, signs and symptoms will be used by the investigator as an aid to treatment decisions

Other: Interventions with heart failure medications

Control

PLACEBO COMPARATOR

Subject will provide information from home regarding weight, signs and symptoms and will perform BNP self testing. All these data will be blinded to the investigator. BNP results will be blinded to the subject.

Other: Interventions with heart failure medications

Interventions

Interventions with heart failure medications OTHER

Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.

BNP + Health Management; Control; Health Management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age and \<75 years of age); AND
• Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered;
• i. BNP \> 300 pg/mL (or NT-pro-BNP \> 1500 pg/mL) during hospital admission or clinic visit.
• OR c. Seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of HF and with signs of worsening HF condition or decompensation, where worsening HF condition is defined as one or more of the following;
• i. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity ii. Symptoms requiring change in dosage of one or more of the following medications:
• diuretic
• beta blocker
• ACE inhibitor iii. Physical evaluation consistent with worsening HF signs (i.e. elevated JVP, ankle edema, dyspnea, abdominal distension, \>4 lb or \>1.8 kg weight increase in past week) iv. HF admission in last 30 days with a documented BNP \> 300 pg/mL (or NT-pro-BNP \> 1500 pg/mL) during or since admission AND d. Presence of left ventricular systolic dysfunction (ejection fraction \<40%); e. Successfully trained and deemed proficient on how to perform a fingerstick and to use the Test System. Each subject will undergo two proficiency assessments.
• The second assessment will be performed following one week (7 days ± 2 days) of home testing to demonstrate retention of the training. Successful completion of this second proficiency assessment will result in randomization of the subject into one of the three study arms of the study. Failure to demonstrate proficiency at this second assessment will result in the withdrawal of the subject from the study.

You may not qualify if:

• Unwilling or unable to provide written informed consent;
• Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis that is concomitant with the primary diagnosis of decompensated HF and for which treatment will be provided.
• Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;
• Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months;
• Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer);
• End stage renal disease (dialysis dependency);
• Receiving any investigational medication;
• Hematocrit outside the 25 to 50% range of the HeartCheck system;
• Prisoner or other institutionalized or vulnerable individual;
• Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver);
• Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions;
• Residence in regions where either transmission of test system data or home visits are not possible.

Sponsors & Collaborators

• Alere San Diego: lead

Study Sites (7)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

St Vincent's Private Hospitale LTd

Dublin, Ireland

Location

University Medical Center Groningen

Gronongen, 9713, Netherlands

Location

University of Auckland

Auckland, 1142, New Zealand

Location

Department of Medicine, University of Otago

Christchurch, New Zealand

Location

Linkoping University Hospital

Linköping, 58185, Sweden

Location

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kenneth McDonald, Professor

  St Vincent's Private Hospitale Ltd, Dublin, Ireland

  STUDY DIRECTOR

• Henry Dargie, Professor

  Western Infirmary, Glasgow, UK

  PRINCIPAL INVESTIGATOR

• Theresa McDonagh, Professor

  Royal Brompton, London, UK

  PRINCIPAL INVESTIGATOR

• John Atherton, Professor

  Royal Brisbane and Women's Hospital, Herston, Australia

  PRINCIPAL INVESTIGATOR

• Henry Krum, Professor

  Monash University

  PRINCIPAL INVESTIGATOR

• Richard Thoughton, Professor

  University of Otago, Christchurch, New Zealand

  PRINCIPAL INVESTIGATOR

• Rob Doughty, Professor

  University of Auckland, Victoria, New Zealand

  PRINCIPAL INVESTIGATOR

• Faiez Zannad, Professor

  Institut Lorrain du Coeur et des Vaisseaux, CHU Nancy, Vandoeuvre-les-Nancy, France

  PRINCIPAL INVESTIGATOR

• Ulf Dahlstrom, Professor

  Linkoping University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• P Van der Meer, Doctor

  University Medical Center Groningen, the Netherlands

  PRINCIPAL INVESTIGATOR

• Franz Kleber, Professor

  Klinikum Ernst von Bergmann, Akademisches Lehrankenhaus der Charite Universitätsmedizin Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

AU (1); SE (1); NL (1); GB (1); IE (1); NZ (2)