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

Heart Failure Clinical Trial

— HOME  

Official title:

HF Outpatient Monitoring Evaluation (HOME) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347567
• Other study ID #: BSTE-0135
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2023
• Source: Abbott RDx Cardiometabolic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Systolic dysfunction heart failure subjects with low ejection fraction and elevated BNP levels admitted to hospital or treated as outpatient for decompensated Heart Failure (HF) are at hight risk for recurrent decompensation and readmission. The objective of this study is to investigate if these patients may benefit from enhanced home monitoring of their HF status.

In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels will be obtained so that frequent data points are available for analysis of trends and variability. These results will remain blinded to the subjects in all study arms and their care providers in the health management and control arms, the investigator and staff will have access to the BNP results only for subjects in the BNP arm and will use this information to aid in therapy decisions.

Subjects are monitored for 180 days as this time period is likely sufficient to differentiate normal biological variation in BNP changes due to impending decompensation.

Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient clinical outcome and treatment adjustments are recorded.

Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will be conducted in order to determine the possible long-term benefit of home health management with daily BNP testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adults (18 years of age and <75 years of age); AND

2. 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:

1. diuretic

2. beta blocker

3. 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.

i. The first assessment will be performed at the time in which the subject is found to meet the inclusion criteria, and deemed willing, able and reliable to complete the study tasks, and following initial training on the use of the test system. Successful completion of this first proficiency assessment will result in the enrolment of the subject into the study.

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.

Exclusion criteria:

1. Unwilling or unable to provide written informed consent;

2. 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.

Note: A history of ACS is not cause for exclusion if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion.

3. Previous cardiac transplantation - or cardiac transplantation anticipated within 3 months;

4. 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;

5. Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer);

6. End stage renal disease (dialysis dependency);

7. Receiving any investigational medication;

8. Hematocrit outside the 25 to 50% range of the HeartCheck system;

9. Prisoner or other institutionalized or vulnerable individual;

10. Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver);

11. Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions;

12. Residence in regions where either transmission of test system data or home visits are not possible.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Other:
• Interventions with heart failure medications
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.

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Ireland	St Vincent's Private Hospitale LTd	Dublin
Netherlands	University Medical Center Groningen	Gronongen
New Zealand	University of Auckland	Auckland
New Zealand	Department of Medicine, University of Otago	Christchurch
Sweden	Linkoping University Hospital	Linkoping
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Alere San Diego

Countries where clinical trial is conducted

Australia,  Ireland,  Netherlands,  New Zealand,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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