Trial Outcomes & Findings for Hemodynamic Effects of Compression in POTS (NCT NCT03484273)

Results Overview

The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

Results posted on

2021-10-22

Participant Flow

This was a randomized cross-over trial. Participants were assigned to receive the 4 compressions interventions in a randomized order. There were a total of 24 potential sequence orders of the compression interventions.

Participant milestones

Participant milestones
Measure	4 Compression Interventions in Randomized Order Participants completed all 4 compression garment interventions in a random order. There were a total of 24 possible intervention orders. The 4 compression interventions were: Full Compression, Abdominal and Pelvic Compression, Lower Limb Compression and No Compression.
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	4 Compression Interventions in Randomized Order Participants completed all 4 compression garment interventions in a random order. There were a total of 24 possible intervention orders. The 4 compression interventions were: Full Compression, Abdominal and Pelvic Compression, Lower Limb Compression and No Compression.
Overall Study Equipment Malfunction	1
Overall Study Data excluded from analysis	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Compression n=30 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.
Age, Continuous	32 years STANDARD_DEVIATION 11 • n=30 Participants
Sex: Female, Male Female	28 Participants n=30 Participants
Sex: Female, Male Male	2 Participants n=30 Participants
Region of Enrollment Canada	30 Participants n=30 Participants
Body Mass Index (BMI)	24 kg/m^2 STANDARD_DEVIATION 6 • n=30 Participants

PRIMARY outcome

Timeframe: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

Population: This was a crossover trial. A total of 30 participants were analyzed.

The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

Outcome measures

Outcome measures
Measure	Full Compression n=30 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=30 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=30 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=30 Participants None of the LifeWrap compression garment straps will be secured.
Orthostatic Heart Rate (HR) Change	23 beats per minute Standard Deviation 11	28 beats per minute Standard Deviation 11	34 beats per minute Standard Deviation 14	39 beats per minute Standard Deviation 18

SECONDARY outcome

Timeframe: During minutes 5-10 of the HUT

Population: This was a crossover trial. A total of 30 participants were analyzed.

The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.

Outcome measures

Outcome measures
Measure	Full Compression n=30 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=30 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=30 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=30 Participants None of the LifeWrap compression garment straps will be secured.
Maximum Upright Heart Rate	92 beats per minute (bpm) Standard Deviation 14	97 beats per minute (bpm) Standard Deviation 15	103 beats per minute (bpm) Standard Deviation 16	109 beats per minute (bpm) Standard Deviation 19

SECONDARY outcome

Timeframe: After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)

Population: This was a crossover trial. A total of 30 participants were analyzed.

Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms. The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study. The VOSS score has been previously used in multiple publications

Outcome measures

Outcome measures
Measure	Full Compression n=30 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=30 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=30 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=30 Participants None of the LifeWrap compression garment straps will be secured.
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating	12 units on a scale Standard Deviation 10	15 units on a scale Standard Deviation 12	22 units on a scale Standard Deviation 17	26 units on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

Change in continuous systolic blood pressure between supine and HUT during each study arm.

Outcome measures

Outcome measures
Measure	Full Compression n=29 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=29 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=29 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=29 Participants None of the LifeWrap compression garment straps will be secured.
Change in Systolic Blood Pressure (SBP)	-5 mmHg Standard Deviation 7	-7 mmHg Standard Deviation 8	-10 mmHg Standard Deviation 10	-10 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

Change in Stroke Volume from supine to HUT in each of the study arms.

Outcome measures

Outcome measures
Measure	Full Compression n=29 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=29 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=29 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=29 Participants None of the LifeWrap compression garment straps will be secured.
Changes in Stroke Volume	-22 mL Standard Deviation 12	-22 mL Standard Deviation 12	-33 mL Standard Deviation 14	-34 mL Standard Deviation 11

SECONDARY outcome

Timeframe: During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

Change in Cardiac Output from supine to HUT in each of the study arms.

Outcome measures

Outcome measures
Measure	Full Compression n=29 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=29 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=29 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=29 Participants None of the LifeWrap compression garment straps will be secured.
Change in Cardiac Output (CO)	0.1 L/min Standard Deviation 0.7	0.3 L/min Standard Deviation 0.7	-0.2 L/min Standard Deviation 1	-0.2 L/min Standard Deviation 0.8

SECONDARY outcome

Timeframe: During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.

Outcome measures

Outcome measures
Measure	Full Compression n=29 Participants The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.	Abdominal and Pelvic Compression n=29 Participants The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.	Lower Limb Compression n=29 Participants The Lifewrap compression garment calf and ankle straps only will be secured.	No Compression n=29 Participants None of the LifeWrap compression garment straps will be secured.
Change in Systemic Vascular Resistance (SVR)	-31 dyne*s/cm^5 Standard Deviation 132	-63 dyne*s/cm^5 Standard Deviation 152	-22 dyne*s/cm^5 Standard Deviation 157	4.7 dyne*s/cm^5 Standard Deviation 145

SECONDARY outcome

Timeframe: During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Change in cerebral blood flow from supine to HUT in each of the study arms.

Outcome measures

Outcome data not reported

Adverse Events

Full Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Abdominal and Pelvic Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lower Limb Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Satish R. Raj

University of Calgary

Phone: 403-210-6152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place