Trial Outcomes & Findings for Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial) (NCT NCT00480077)

NCT ID: NCT00480077

Last Updated: 2025-07-02

Results Overview

Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 335 participants
• Primary outcome timeframe: 14.9 ± 5.4 months
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	Access Arm HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass
Overall Study STARTED	168	167
Overall Study COMPLETED	137	141
Overall Study NOT COMPLETED	31	26

Reasons for withdrawal

Measure	Access Arm HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass
Overall Study Death	19	15
Overall Study early exit	12	11

Baseline Characteristics

Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)

Baseline characteristics by cohort

Measure	Access Arm n=168 Participants HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm n=167 Participants HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass	Total n=335 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=5 Participants	64 years STANDARD_DEVIATION 10 • n=7 Participants	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	142 Participants n=7 Participants	288 Participants n=5 Participants
QRS duration	142 ms STANDARD_DEVIATION 39 • n=5 Participants	143 ms STANDARD_DEVIATION 36 • n=7 Participants	142 ms STANDARD_DEVIATION 38 • n=5 Participants
Body Mass Index	28 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	27 kg/m^2 STANDARD_DEVIATION 4 • n=7 Participants	28 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants
NYHA functional class NYHA functional class I	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
NYHA functional class NYHA functional class II	98 participants n=5 Participants	103 participants n=7 Participants	201 participants n=5 Participants
NYHA functional class NYHA functional class III	63 participants n=5 Participants	58 participants n=7 Participants	121 participants n=5 Participants
NYHA functional class NYHA functional class IV	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
LVEF	25 % STANDARD_DEVIATION 7 • n=5 Participants	25 % STANDARD_DEVIATION 7 • n=7 Participants	25 % STANDARD_DEVIATION 7 • n=5 Participants
Type of device implanted CRT-D	141 Participants n=5 Participants	133 Participants n=7 Participants	274 Participants n=5 Participants
Type of device implanted ICD	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14.9 ± 5.4 months

Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

Outcome measures

Measure	Access Arm n=168 Participants HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm n=167 Participants HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass
Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization	48 Participants	33 Participants

Adverse Events

Access Arm

Serious events: 50 serious events

Other events: 47 other events

Deaths: 0 deaths

Control Arm

Serious events: 34 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Access Arm n=168 participants at risk HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm n=167 participants at risk HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass
Blood and lymphatic system disorders Anaemia	0.00% 0/168 • mean follow up period (months): 14.9 +/- 5.4	1.2% 2/167 • Number of events 2 • mean follow up period (months): 14.9 +/- 5.4
Cardiac disorders Cardiac failure	23.2% 39/168 • Number of events 57 • mean follow up period (months): 14.9 +/- 5.4	13.8% 23/167 • Number of events 32 • mean follow up period (months): 14.9 +/- 5.4
Infections and infestations Pneumonia	3.6% 6/168 • Number of events 6 • mean follow up period (months): 14.9 +/- 5.4	2.4% 4/167 • Number of events 5 • mean follow up period (months): 14.9 +/- 5.4
Injury, poisoning and procedural complications Lead Dislodgement	2.4% 4/168 • Number of events 4 • mean follow up period (months): 14.9 +/- 5.4	1.8% 3/167 • Number of events 3 • mean follow up period (months): 14.9 +/- 5.4
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.60% 1/168 • Number of events 1 • mean follow up period (months): 14.9 +/- 5.4	1.2% 2/167 • Number of events 3 • mean follow up period (months): 14.9 +/- 5.4

Other adverse events

Measure	Access Arm n=168 participants at risk HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass	Control Arm n=167 participants at risk HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass
Cardiac disorders Cardiac failure	4.2% 7/168 • Number of events 10 • mean follow up period (months): 14.9 +/- 5.4	1.8% 3/167 • Number of events 3 • mean follow up period (months): 14.9 +/- 5.4
Cardiac disorders Ventricular tachycardia	4.2% 7/168 • Number of events 9 • mean follow up period (months): 14.9 +/- 5.4	0.00% 0/167 • mean follow up period (months): 14.9 +/- 5.4
General disorders Chest pain	4.8% 8/168 • Number of events 9 • mean follow up period (months): 14.9 +/- 5.4	1.8% 3/167 • Number of events 3 • mean follow up period (months): 14.9 +/- 5.4
General disorders Oedema peripheral	3.6% 6/168 • Number of events 8 • mean follow up period (months): 14.9 +/- 5.4	1.8% 3/167 • Number of events 4 • mean follow up period (months): 14.9 +/- 5.4
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.3% 19/168 • Number of events 24 • mean follow up period (months): 14.9 +/- 5.4	6.6% 11/167 • Number of events 13 • mean follow up period (months): 14.9 +/- 5.4

Additional Information

Director CRDM

Medtronic Bakken Research Center

Phone: 31-43-3566813

Results disclosure agreements

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