Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors

Heart Failure Clinical Trial

— AIM-POWER  

Official title:

Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04191330
• Other study ID #: BV-EV-HF-1901
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Biofourmis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHF platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects.

Description:

Patients with heart failure (HF) remain at high risk for hospitalization and death in part due to underuse of guideline directed medical therapy (GDMT). Digital interventions may facilitate rapid initiation, titration and optimization of GDMT but have not been systematically evaluated in randomized control trials. In the AIM-POWER study, we evaluated the safety and efficacy of a novel software medical application, BiovitalsHF, as a strategy to guide remote optimization of GDMT in patients with HF with reduced ejection fraction (HFrEF).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: August 31, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible to be included in the study only if all the following criteria apply:

• Written informed consent must be obtained before any assessment is performed

• Age = 22 years at signing of informed consent

• Diagnosis of heart failure with left ventricular ejection fraction = 40%, EF can be assessed by any validated method, but assessment must have occurred within the last year.

• HFrEF patient not on optimal GDMT defined as:

Participant not on optimal GDMT for HFrEF per investigator judgement. This would include patients ranging from no treatments for HFrEF to a patient on multiple GDMTs for HFrEF but with at least 1 medication at 50% or less than target dose.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

Therapy related

• Absolute contraindications to HF GDMT Disease related

• Heart failure hospitalization in the past 28 days.

• Baseline creatinine > 2 mg/dl or potassium level at baseline, =5 mEq/L or eGFR <30 mL/min/1.73 m2

• Receiving dialysis at screening

• Baseline systolic blood pressure <100 mmHg

• History of heart transplant or on transplant list

• Current or planned left ventricular assist device Comorbidity or other medical conditions

• Uncontrolled asthma

• Active wheezing on physical exam

• Uncontrolled severe COPD

• Diagnosed with cirrhosis

• Currently being treated for active malignancy and life expectancy is less than one year

• Currently receiving hospice or comfort care Prior or concurrent clinical study experience

• Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study Other General Exclusions

• Subject unable to independently navigate and operate smartphone applications

• Subject not proficient with written and spoken English or Spanish

• Subject determined likely to be non-compliant by physician/HCP

• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.

• History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Biofourmis medical monitor, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

• Subject has diminished decision making capability

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BiovitalsHF
BiovitalsHFTM is a cloud-based platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.

Locations

Country	Name	City	State
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Piedmont Athens Regional Medical Center	Athens	Georgia
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Premier Cardiovascular Institute	Dayton	Ohio
United States	Jackson Heart	Jackson	Mississippi
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Cardiology and Medicine Clinic	Little Rock	Arkansas
United States	Baptist Health Louisville Heart Failure Clinic	Louisville	Kentucky
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Providence St Vincent Medical Center	Portland	Oregon
United States	Austin Heart	San Marcos	Texas
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	St Joseph Mercy	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Biofourmis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life and function	• Change in KCCQ-23	90 days
Primary	• To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx to improve guideline-directed medical therapy (GDMT) adoption in subjects with heart failure with reduced ejection fraction (HFrEF) after 90 days of using the platform	The primary endpoint will be the between-group difference in the change at 90 days, between the intervention and control arm in heart failure optimal therapy score.; Heart Failure Optimal Therapy Score: A heart failure optimal therapy score was developed (see Table S9 below) based on clinical practice guidelines, including the 2021 Update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment {REF}. One point is awarded for initiating evidence-based BB, MRA, or ARNI and two points for up titrating those classes of medications to 50% or higher target dose. Two points are awarded for initiating SGLT2 inhibitor as there is a single approved dose (and no opportunity for dose titration). Finally, if a patient is not on an ARNI, one point is awarded for ACEi/ARB at 50% or higher target dose. Of note, ARNI patients do not receive points for ACEi/ARB. The maximum possible score is 8 points, and the minimum possible score is 0 points.	90 days
Secondary	• To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTX to improve the composite clinical outcome by calculating the win ratio between treatment and control arm.	A win ratio [13] will be used to analyze the composite endpoints in the following order of clinical importance: Time to CV death; Time to heart failure related hospitalization; Improvement in GDMT score; Improvement in KCCQ score; Reduction on NTproBNP by 30% compared to baseline (TABLE 3)	90 days
Secondary	• To assess the effectiveness of the Biofourmis cloud based BiovitalsHF DTx to help improve GDMT adoption and on clinical outcomes.	• The key secondary endpoint will be the percentage of subjects on target dose of GDMT. Comparisons between the control and intervention arm will be based on the CHAMP-HF registry design [4]. At baseline, day 90, and day 180, subjects will be divided into one of four groups according to prescribed dose of GDMT: subjects not receiving medication, subjects treated with <50% target dose, subjects treated with 50 to <100% target dose, and subjects treated with >100% target dose.	90 days
Secondary	GDMT initiation	• Initiation of evidence-based beta-blocker, ACEi/ARB/ARNI, MRA or SGLT2 inhibitors including proportion of subjects switching from ACEi/ARB to ARNI	90 days
Secondary	Quadruple therapy	• Proportion of subjects on 4 GDMT drug classes	90 days
Secondary	Time to GDMT optimization	• Time taken to achieve 50% target dose between control and intervention arms.	90 days
Secondary	Change in biomarkers	• Change in NT-pro-BNP	90 days
Secondary	Safety outcomes	Incidence of worsening renal function (i.e., defined as an increase in serum creatinine > 0.5 mg/dl); Incidence of symptomatic postural hypotension (defined as dizziness, lightheadedness, or syncope due to low blood pressure); Objective evidence of hypotension (SBP < 90 mmHg); Incidence of hyperkalemia (i.e., defined K = __5.5 mEq/L); Incidence of angioedema; Incidence of severe bradycardia (i.e., defined as an average heart rate < 50 bpm for 12 hours in one day or for 4 contiguous hours)	90 days