Trial Outcomes & Findings for Multiple Cardiac Sensors for the Management of Heart Failure (NCT NCT03237858)

NCT ID: NCT03237858

Last Updated: 2024-03-27

Results Overview

Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
• Results posted on: 2024-03-27

Participant Flow

Manage-HF Phase I began recruitment in August of 2017 and completed recruitment in May of 2019. Last Patient Last visit for Phase I occurred in July of 2020. MANAGE HF Phase I was determined to be sufficient by FDA on January 31, 2023, and phase II was not started.

Participant milestones

Measure	MANAGE-HF Phase I Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit. Thirty-seven subjects withdrew and 19 subjects died.
Overall Study STARTED	200
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	56

Reasons for withdrawal

Measure	MANAGE-HF Phase I Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit. Thirty-seven subjects withdrew and 19 subjects died.
Overall Study Death	19
Overall Study Withdrawal by Subject	37

Baseline Characteristics

Multiple Cardiac Sensors for the Management of Heart Failure

Baseline characteristics by cohort

Measure	MANAGE-HF Phase I n=191 Participants Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit. Thirty-seven subjects withdrew and 19 subjects died.
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	171 participants n=5 Participants
Region of Enrollment France	14 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants
Heart Failure Hospitalization	112 Participants n=5 Participants
Ischemic Heart Disease	90 Participants n=5 Participants
Dilated Cardiomyopathy	75 Participants n=5 Participants
Idiopathic Cardiomyopathy	20 Participants n=5 Participants
Valvular disease	48 Participants n=5 Participants
Valvular surgery	17 Participants n=5 Participants
Thoracic surgery	18 Participants n=5 Participants
Previous Myocardial Infarction	73 Participants n=5 Participants
CABG	49 Participants n=5 Participants
QRS duration (ms)	135 ms STANDARD_DEVIATION 31 • n=5 Participants
LVEF (%)	25.6 % STANDARD_DEVIATION 9.5 • n=5 Participants
RVEF (%)	49.3 % STANDARD_DEVIATION 12.5 • n=5 Participants
Chronic Obstructive Pulmonary Disease	28 participants n=5 Participants
Asthma	12 Participants n=5 Participants
Pulmonary hypertension	14 Participants n=5 Participants
Pulmonary diseases other	13 Participants n=5 Participants
Peripheral Vascular Disease	25 Participants n=5 Participants
Renal dysfunction	50 Participants n=5 Participants
Hypertension	144 Participants n=5 Participants
Diabetes	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit

Population: Manage-HF Phase II was not started, the trial was closed after phase I

Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.

Outcome measures

Measure	MANAGE-HF Phase I n=191 Participants Number of participants contributing to the knowledge of the clinical integration of HeartLogic and the alert management process
Manage-HF Phase I	191 Participants

Adverse Events

MANAGE-HF Phase I

Serious events: 100 serious events

Other events: 104 other events

Deaths: 19 deaths

Serious adverse events

Measure	MANAGE-HF Phase I n=200 participants at risk MANAGE-HF Phase I was an open label, non-randomized single arm study
Cardiac disorders Pulse Generator	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders RA Lead	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders RV Lead	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Cardiovascular-HF	25.0% 50/200 • Number of events 92 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Cardiovascular-Non-HF	27.5% 55/200 • Number of events 79 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Non-cardiovascular	31.5% 63/200 • Number of events 130 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I

Other adverse events

Measure	MANAGE-HF Phase I n=200 participants at risk MANAGE-HF Phase I was an open label, non-randomized single arm study
Cardiac disorders Pulse Generator	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders RA Lead	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders RV Lead	0.00% 0/200 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Cardiovascular-HF	41.0% 82/200 • Number of events 227 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Cardiovascular-Non-HF	25.5% 51/200 • Number of events 83 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I
Cardiac disorders Non-cardiovascular	15.0% 30/200 • Number of events 59 • Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit Manage-HF Phase II was not started, the study was closed after Phase I

Additional Information

Joe Hobbs, Clinical Trial Manager

Boston Scientific

Phone: 612-206-4703

Email: JOE.HOBBS@BSCI.COM

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place