ASAP-HF: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT02963597
• Collaborator: Resmed Inc (Other)
• Enrollment: 21
• Locations: 2
• Arms: 2
• Actual Duration (Months): 22.4
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Hypertension, Pulmonary; Heart Failure	Device: AirSense™ 10 AutoSet; Other: Standard Medical Therapy	N/A

Detailed Description

The ASAP-HF study is a prospective, randomized, controlled, two-center, study with a parallel group design, with subjects randomized to either control (no APAP) or active treatment (APAP) in a 1:1 ratio. Group A (active): standard medical therapy plus treatment with continuous APAP for 48hrs, or Group B (control): standard medical therapy only.

Many people who have heart failure (HF) also have sleep-disordered breathing (SDB), which is breathing irregularities during sleep. These irregularities may interrupt the sleep as well as increase the rate of progression of Heart Failure. The ASAP-HF study is being done to see if certain clinical outcomes are improved in acute decompensated heart failure (HF) patients with SDB by using a non-invasive breathing device continuously for a short period of time (48 hours) while patient is still in the hospital. The device is called AirSense™ 10 AutoSet (AutoSet). It consists of an air flow generator, air tubing, an air humidifier, and a mask. As the patient breathe through the mask, the AutoSet monitors breathing.

The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters . This device is not currently used to diagnose sleep apnea and its utility is not well studied. This study will establish the utility of the device in diagnosing sleep apnea.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: CPAP DeviceCPAP Device
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.	Device: AirSense™ 10 AutoSet; The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.; Other: Standard Medical Therapy; Standard medical therapy according to current guidelines.
Placebo Comparator: Group B Standard medical therapy only.	Other: Standard Medical Therapy; Standard medical therapy according to current guidelines.

Outcome Measures

Primary Outcome Measures

1. Pulmonary Artery Systolic Pressure. [48 hours]

   The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.

Secondary Outcome Measures

1. Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs [48 hours]

   6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters.

2. N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs [48 hours]

   To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after.

3. Length of Stay [1 year]

   The total stay in the hospital during the admission will be measured by days.

4. Blood Oxygenation. [48 hours]

   Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen.

5. Heart Failure Symptoms [48 hours]

   Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes. Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

6. Fluid Retention [48 hours]

   Change in fluid retention as measured by weight at baseline and after 48 hours.

7. E/e' as an Assumption of LVEDP. [48 hours]

   Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years or more

2. Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure)

3. Prior clinical diagnosis of heart failure

4. Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time)

5. Patient is able to fully understand study information and sign informed consent

Exclusion Criteria:

1. Chronic renal insufficiency (Hemodialysis or serum creatinine > 2)

2. Hemodynamically significant valvular disease

3. Severe arthritis or inability to complete 6 Minute Walk Test

4. Left Ventricular Assist Device/ heart transplant or hemodynamically unstable

5. Patient taking any Pulmonary vasodilators, including home oxygen.

6. Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy

7. 80% of the respiratory events being central/Cheyne-Stokes breathing

8. Recent cardiac surgery (within 30 days of admission)

9. Recent stroke (within 30 days of admission or with persistent neurological deficits)

10. Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania	United States	19141
2	Heart and Diabetes Center NRW	Bad Oeynhausen	North Rhine-Westphalia	Germany	32545

Sponsors and Collaborators

• Albert Einstein Healthcare Network
• Resmed Inc

Investigators

• Principal Investigator: Sunil Sharma, MD, Albert Einstein Healthcare Network

Study Documents (Full-Text)

• Study Protocol - May 30, 2017
• Statistical Analysis Plan - May 30, 2017

More Information

Publications

None provided.

• Responsible Party: Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT02963597
• Other Study ID Numbers: 4889
• First Posted: Nov 15, 2016
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Hypertension, Pulmonary; Sleep Apnea, Obstructive; Hypertension; Heart Failure

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the inpatient clinical services of the Albert Einstein Medical Center Philadelphia (US) and from the Heart and Diabetes Center of North Rhine-Westphalia (Germany). Patients signed an informed consent for the study prior to any study-related procedure. Before randomization, all eligibility criteria were confirmed.

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Period Title: Overall Study
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group A	Group B	Total
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provides non-invasive ventilatory support to treat patients with sleep-disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in the sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.6 (11.5)	64.9 (9.96)	67.75 (10.8)
Sex: Female, Male (Count of Participants)
Female	3 30%	4 36.4%	7 33.3%
Male	7 70%	7 63.6%	14 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 50%	4 36.4%	9 42.9%
White	5 50%	7 63.6%	12 57.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	5 50%	5 45.5%	10 47.6%
Germany	5 50%	6 54.5%	11 52.4%
Body mass index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	28.7 (5.8)	31.2 (4.2)	30.0 (5.0)
Type of heart failure according to EF (HFrEF/HFpEF) (Count of Participants)
HFpEF	5 50%	3 27.3%	8 38.1%
HFrEF	5 50%	8 72.7%	13 61.9%
Smoking history (Count of Participants)
Active smoker	1 10%	2 18.2%	3 14.3%
Former smoker	3 30%	3 27.3%	6 28.6%
Never smoker	6 60%	6 54.5%	12 57.1%
History of COPD (Count of Participants)
Diagnosis of COPD confirmed with PFTs	4 40%	1 9.1%	5 23.8%
No diagnosis of COPD or negative PFTs	6 60%	10 90.9%	16 76.2%
Apnea-hypopnea index (AHI) (events/hour) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [events/hour]	31.7 (8)	34.3 (9.2)	33.1 (8.5)

Outcome Measures

1. Primary Outcome

Title	Pulmonary Artery Systolic Pressure.
Description	The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Patients pulmonary artery systolic pressures were measured by transthoracic echocardiography (TTE) on admission and 48 hours after enrollment.

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	58.6	62.7
After 48 hours	42.8	57.5

2. Secondary Outcome

Title	Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
Description	6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	202.6	153.6
After 48 hours	222.6	161.8

3. Secondary Outcome

Title	N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
Description	To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	1087.6	1532.7
After 48 hours	466.5	1500.2

4. Secondary Outcome

Title	Length of Stay
Description	The total stay in the hospital during the admission will be measured by days.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Mean (95% Confidence Interval) [days]	9.2	13.7

5. Secondary Outcome

Title	Blood Oxygenation.
Description	Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Data was not available for all participants.

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	72.84	76.7
After 48 hours	80	77.9

6. Secondary Outcome

Title	Heart Failure Symptoms
Description	Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes. Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Data was not available for participants after 48 hours. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	3.2	3.5

7. Secondary Outcome

Title	Fluid Retention
Description	Change in fluid retention as measured by weight at baseline and after 48 hours.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Data after 48 hours was not available for the participants of the study. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	82.6	94.7

8. Secondary Outcome

Title	E/e' as an Assumption of LVEDP.
Description	Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Data was not available for all the subjects at baseline and 48 hours after. PI has left the institution; efforts to contact unsuccessful; clarifying data information not available

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	11
Baseline	18.6	18.2
After 48 hours	14.8	16.5

9. Post-Hoc Outcome

Title	Ejection Fraction in HFrEF
Description	Calculated ejection fraction in patients with heart failure with reduced ejection fraction (<45%) at baseline and after 48 hours.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Analyzing only patients with heart failure with reduced ejection fraction (<45%).

Arm/Group Title	Group A	Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.	Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
Measure Participants	10	10
Baseline	23	26.8
After 48 hours	30	26.7

Adverse Events

Time Frame	1 year.
Arm/Group Title	Group A		Group B
Arm/Group Description	Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines.		Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines.
All Cause Mortality
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

PI has left the institution; efforts to contact unsuccessful; additional data information not available

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.