Trial Outcomes & Findings for Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure (NCT NCT02698241)

Last Updated: 2019-12-30

Results Overview

The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Effectiveness of this intervention strategy was measured as the percentage of implemented interventions being effective. Once initiated, an Integrated Diagnostic Medication Intervention would be effective if all the following criteria were met: 1. The intrathoracic impedance of a subject recovered per defined criterion after completion of the Integrated Diagnostic Medication Intervention; 2. The subject had no HF-related event (as adjudicated by the CEC) during or in the next 14 days after completion of the Integrated Diagnostic Medication Intervention; 3. The subject had not experienced any adverse events that were related to the Integrated Diagnostic Medication Intervention per CEC adjudication and require medical care.

Recruitment status

TERMINATED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

12 months post enrollment

Results posted on

2019-12-30

Participant Flow

A screening visit was required after a subject signed the informed consent form and before the baseline and programming visit. During the screening visit, subject's OptiVol Fluid Index and bloodwork were verified for the eligibility to continue the study. If subject failed the screening, he/she would exit the study.

Participant milestones

Participant milestones
Measure	Device Diagnostic & Diuretic and Chronic Medication Management Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Overall Study STARTED	79
Overall Study Baseline & Programming	66
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Device Diagnostic & Diuretic and Chronic Medication Management Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Overall Study Inclusion/exclusion criteria not met	4
Overall Study Screening not met	7
Overall Study Withdrawal by Subject	7
Overall Study Physician Decision	2
Overall Study Subject underwent system modification	2
Overall Study Lost to Follow-up	3
Overall Study Subject on inodrip not safe to continue	6
Overall Study geographic and licensing issue	1
Overall Study Death	2

Baseline Characteristics

Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Diagnostic & Diuretic and Chronic Medication Management n=66 Participants Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Age, Continuous	72.9 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	9 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants
BMI	28.1 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants
Systolic BP	119.6 mmHg STANDARD_DEVIATION 17.7 • n=5 Participants
Diastolic BP	70.6 mmHg STANDARD_DEVIATION 9.4 • n=5 Participants
NYHA Class Class I	0 Participants n=5 Participants
NYHA Class Class II	27 Participants n=5 Participants
NYHA Class Class III	39 Participants n=5 Participants
NYHA Class Class IV	0 Participants n=5 Participants
Having heart failure events in previous 6 months Yes	13 Participants n=5 Participants
Having heart failure events in previous 6 months No	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the effectiveness of the implemented interventions.

Outcome measures

Outcome measures
Measure	Device Diagnostic & Diuretic and Chronic Medication Management n=26 Interventions Implemented Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)	69.2 percentage of effective interventions

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the safety of implemented interventions

The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Safety of this intervention strategy was measured as the percentage of implemented interventions being safe. Once initiated, the Integrated Diagnostic Medication Intervention Strategy would be regarded as being safe if all the following criteria were met: 1. The Integrated Diagnostic Medication Intervention applied to an episode was not terminated due to safety issues; 2. The Integrated Diagnostic Medication Intervention applied to an episode had not caused treatment-related adverse events (as adjudicated by the CEC).

Outcome measures

Outcome measures
Measure	Device Diagnostic & Diuretic and Chronic Medication Management n=26 Interventions Implemented Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)	84.6 percentage of safe interventions

Adverse Events

Device Diagnostic & Diuretic and Chronic Medication Management

Serious events: 34 serious events

Other events: 13 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Device Diagnostic & Diuretic and Chronic Medication Management n=79 participants at risk Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Cardiac disorders Acute coronary syndrome	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Angina pectoris	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Atrial fibrillation	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Atrial flutter	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Cardiac failure	12.7% 10/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Cardiac failure congestive	7.6% 6/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Cardio-respiratory arrest	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Coronary artery disease	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Coronary artery stenosis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Mitral valve incompetence	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Cardiac disorders Ventricular tachycardia	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
General disorders Generalised oedema	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Hepatobiliary disorders Ischaemic hepatitis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Bronchitis	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Cellulitis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Clostridium difficile infection	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Herpes zoster	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Infective exacerbation of bronchiectasis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Pneumonia	5.1% 4/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Pneumonia bacterial	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Staphylococcal bacteraemia	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Infections and infestations Staphylococcal sepsis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Metabolism and nutrition disorders Hyperkalaemia	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Metabolism and nutrition disorders Hyponatraemia	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Nervous system disorders Presyncope	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Nervous system disorders Syncope	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Product Issues Device battery issue	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Product Issues Device lead damage	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Renal and urinary disorders Acute kidney injury	6.3% 5/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Reproductive system and breast disorders Breast mass	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.5% 2/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Skin and subcutaneous tissue disorders Diabetic foot	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Vascular disorders Air embolism	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Vascular disorders Hypotension	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Vascular disorders Hypovolaemic shock	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Vascular disorders Orthostatic hypotension	1.3% 1/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).

Other adverse events

Other adverse events
Measure	Device Diagnostic & Diuretic and Chronic Medication Management n=79 participants at risk Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study.
Cardiac disorders Cardiac failure	10.1% 8/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).
Vascular disorders Hypotension	6.3% 5/79 • In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months. Only the following adverse events were monitored/assessed: all system-related adverse events (AEs), all cardiovascular-related AEs, all AEs that might be associated with the PRN intervention, and all serious adverse events (SAEs).

Additional Information

Joe Hobbs Clinical Research Specialist

Medtronic CRHF Clinical Research

Phone: 800-633-8766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place