Trial Outcomes & Findings for Local Heat Stress in Autonomic Failure Patients With Supine Hypertension (NCT NCT02417415)

NCT ID: NCT02417415

Last Updated: 2022-03-10

Results Overview

Change from baseline in systolic blood pressure at 2 hr post-intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 2 hours of heat stress or sham
• Results posted on: 2022-03-10

Participant Flow

Participant milestones

Measure	Local Heat Stress Then Sham Control Passive heat-stress of 40-42 degrees applied with an electric heating pad over the abdomen and part of the torso for up to 2 hours on study day 1 and sham control (heating pad turned off for up to 2 hours) on study day 2	Sham Control Then Local Heat Stress Sham control (heating pad turned off for up to 2 hours) on study day 1 and local heat stress of 40-42 degrees applied with an electric heating pad over the abdomen and part of the torso for up to 2 hours on study day 2.
Overall Study STARTED	13	9
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood samples could not be obtained in 3 subjects

Baseline characteristics by cohort

Measure	All Study Participants n=22 Participants Participants who were randomized to receive local passive heat stress and sham control in any order.
Age, Continuous	73 years STANDARD_DEVIATION 6 • n=22 Participants
Sex: Female, Male Female	6 Participants n=22 Participants
Sex: Female, Male Male	16 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants
Race (NIH/OMB) Asian	0 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	1 Participants n=22 Participants
Race (NIH/OMB) White	21 Participants n=22 Participants
Race (NIH/OMB) More than one race	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants
BMI	27 kg/m^2 STANDARD_DEVIATION 4 • n=22 Participants
Disease Duration	7 years STANDARD_DEVIATION 4 • n=22 Participants
Diagnosis Pure Autonomic Failure	14 Participants n=22 Participants
Diagnosis Parkinson Disease + Autonomic Failure	7 Participants n=22 Participants
Diagnosis Multiple System Atrophy	1 Participants n=22 Participants
Medical history of essential hypertension	10 Participants n=22 Participants
Heat intolerance	15 Participants n=22 Participants
Systolic BP, supine	170 mm Hg STANDARD_DEVIATION 23 • n=22 Participants
Systolic BP, upright	100 mm Hg STANDARD_DEVIATION 33 • n=22 Participants
Heart rate, supine	67 bpm STANDARD_DEVIATION 12 • n=22 Participants
Heart rate, upright	77 bpm STANDARD_DEVIATION 11 • n=22 Participants
Plasma norepinephrine, supine	132 pg/mL STANDARD_DEVIATION 70 • n=19 Participants • Blood samples could not be obtained in 3 subjects
Plasma norepinephrine, upright	199 pg/mL STANDARD_DEVIATION 136 • n=20 Participants • Blood samples could not be obtained in 2 subjects

PRIMARY outcome

Timeframe: 2 hours of heat stress or sham

Change from baseline in systolic blood pressure at 2 hr post-intervention

Outcome measures

Measure	Local Heat Stress n=22 Participants Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso Passive heat stress: Passive heat stress was applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at 40-42 degrees continuously for 2 hr.	Control (Non-heating) n=22 Participants Commercial heating pad applied over the abdomen and part of the torso but turned off Control (non-heating): Heating pad was applied over the abdomen and part of the torso but it will be turned off for up to 2 hours
Change in Systolic Blood Pressure	19 mm Hg Standard Error 4	3 mm Hg Standard Error 4

SECONDARY outcome

Timeframe: 2 hours of heat stress or sham

Population: Systemic hemodynamics were measured in 13 of the 22 participants

Percent change from baseline ([post-intervention - baseline]/baseline X 100) in cardiac output, stroke volume and systemic vascular resistance at 2 hours post-intervention

Outcome measures

Measure	Local Heat Stress n=13 Participants Passive heat-stress using a commercial heating pad applied over the abdomen and part of the torso Passive heat stress: Passive heat stress was applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at 40-42 degrees continuously for 2 hr.	Control (Non-heating) n=13 Participants Commercial heating pad applied over the abdomen and part of the torso but turned off Control (non-heating): Heating pad was applied over the abdomen and part of the torso but it will be turned off for up to 2 hours
Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance) Cardiac Output	-15 percentage change Standard Error 5	-2 percentage change Standard Error 4
Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance) Stroke Volume	-18 percentage change Standard Error 5	-4 percentage change Standard Error 4
Percent Change in Hemodynamic Parameters (Cardiac Output, Stroke Volume and Systemic Vascular Resistance) Systemic Vascular Resistance	9 percentage change Standard Error 6	4 percentage change Standard Error 5

Adverse Events

Local Heat Stress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Non-heating)

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

Italo Biaggioni

Vanderbilt University Medical Center

Phone: (615) 322-2318

Email: italo.biaggioni@vumc.org

Results disclosure agreements

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