PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure

• Sponsor: Fresenius Medical Care Deutschland GmbH (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03161158
• Collaborator: (none)
• Enrollment: 62
• Locations: 11
• Arms: 2
• Actual Duration (Months): 21.7
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Acute Heart Failure	Device: CHIARA-System; Other: Usual care IV diuretics	N/A

Detailed Description

The study will evaluate whether stepped, peripheral ultrafiltration complementary to low-dose diuretics influences 90-day clinical outcomes compared to usual care including intravenous diuretics in symptomatic heart failure patients with persistent congestion. Hospitalized subjects will be randomly assigned to receive either a tailored, peripheral ultrafiltration approach complementary to intravenous low-dose diuretics and other guideline-directed medical therapy OR high-dose diuretic therapy and other Guideline-directed medical therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multicenter, prospective, randomized, parallel-group, controlledMulticenter, prospective, randomized, parallel-group, controlled
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
• Actual Study Start Date: Nov 3, 2017
• Actual Primary Completion Date: Aug 26, 2019
• Actual Study Completion Date: Aug 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultrafiltration Group Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.	Device: CHIARA-System; Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.; Other Names: Low-dose IV diuretics
Other: Control group (Usual care IV diuretics) Guideline-directed therapy including IV loop diuretics according to treatment algorithm.	Other: Usual care IV diuretics; Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)

Outcome Measures

Primary Outcome Measures

1. Heart Failure (HF) Event [in 90 days after discharge]

   Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.

2. Cardiovascular Death up to 90 Days After Randomization. [in 90 days after discharge]

   The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after ~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes

Eligibility Criteria

Criteria

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

Inclusion Criteria:

General:

Informed consent signed and dated by study patient and investigator/authorised physician

• Minimum age of 18 years

• Ability to understand the nature and requirements of the study

Study-specific:

• Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)

• On regularly scheduled oral loop diuretics prior to admission

• Patients who have received IV loop diuretics for decongestion within 24 hours after hospital admission and prior to screening. The dosages are administered according to clinical judgment.** (**This inclusion criterion was changed with CIP amendment; in former version 3.0 it read "After pre-screening and prior to final screening for eligibility, patients who have received two boluses of IV loop diuretics (Dose according to the Furosemide-Low Intensification, Q12 hour bolus arm of the DOSE trial))

• Symptoms of congestion and clinical evidence at the time of final screening for eligibility:

• Fluid overload manifested by at least 2 of the following:

1. Pitting edema ≥2+ of the lower extremities

2. Jugular venous pressure >8 cm H2O

3. Pulmonary congestion or pleural effusion on chest x-ray

4. Paroxysmal nocturnal dyspnea or ≥2- pillow orthopnea

5. Respiration rate ≥20 per minute

• Additional objective documentation of congestion: Lung or inferior vena cava ultrasound, chest x-ray or elevated filling pressures, if available, at the time of randomization (optional)

Exclusion Criteria:

General:

• Any condition which could interfere with the patient's ability to comply with the study

• In case of female patients, pregnancy or lactation period

• Participation in an interventional clinical study during the preceding 30 days

• Previous participation in the same study

• Unwillingness or inability to complete follow up

• Active drug or alcohol abuse (smoking allowed)

Study-specific:

• Acute coronary syndrome requiring intervention during index hospitalization

• Severe renal dysfunction requiring renal replacement therapy

• Systolic blood pressure < 90 mmHg at the time of randomization

• Pulmonary hypertension not secondary to left heart disease

• Pulmonary disease thought to be primarily responsible for symptoms

• Contraindication to systemic anticoagulation

• Severe concomitant disease expected to prolong hospitalization or to cause death in ≤ 90 days

• Sepsis

• Severe uncorrected valvular stenosis at the time of randomization

• Active myocarditis

• Hypertrophic obstructive cardiomyopathy

• Constrictive pericarditis or restrictive cardiomyopathy

• Liver cirrhosis due to primary liver disease* (*Restriction "due to primary liver disease" was present after amendment in study protocol version 5.0 but not in version 3.0)

• Known infection with human immunodeficiency virus (HIV) or active hepatitis C

• Previous solid organ transplant

• Presence or requirement for mechanical respiratory support

• Presence or requirement of a mechanical circulatory support device

• Need for IV positive inotropic agents at the time of randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Aachen (Med. Klinik II)	Aachen		Germany	52074
2	Helios Klinikum Duisburg	Duisburg		Germany	47166
3	Helios Klinikum Erfurt GmbH	Erfurt		Germany	99089
4	Medizinische Universitätsklinik, Innere Medizin III	Heidelberg		Germany	69120
5	Helios Klinikum Hildesheim GmbH	Hildesheim		Germany	31135
6	Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen	Stuttgart		Germany	70174
7	Falun Hospital	Falun		Sweden	79182
8	Danderyds University Hospital	Stockholm		Sweden	182 88
9	Karolinska University Hospital Huddinge, Department of Cardiology	Stockholm		Sweden	SE-14186
10	Uppsala University Hospital, Department of Cardiology	Uppsala		Sweden	SE-75185
11	Universitetssjukhuset Örebro, Hjärtsviktsmottagningen	Örebro		Sweden	SE-70185

Sponsors and Collaborators

• Fresenius Medical Care Deutschland GmbH

Investigators

• Study Chair: Frank Ruschitzka, Prof Dr med, Universitätsspital Zürich, Klinik für Kardiologie

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 19, 2018

More Information

Publications

None provided.

• Responsible Party: Fresenius Medical Care Deutschland GmbH
• ClinicalTrials.gov Identifier: NCT03161158
• Other Study ID Numbers: UF-HF-02-INT; EUDAMED-No. CIV -17-01-018204
• First Posted: May 19, 2017
• Last Update Posted: May 5, 2021
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fresenius Medical Care Deutschland GmbH: Cardio-Renal Syndrome type 1; Acutely decompensated chronic heart failure; Ultrafiltration
• Additional relevant MeSH terms: Heart Failure; Diuretics

Study Results

Participant Flow

Recruitment Details	Of 62 enrolled patients, 44 were randomized to treatment. 37 patients were included in the safety and full analysis set (SAF/FAS)

Arm/Group Title	Ultrafiltration Group	Control Group (Usual Care IV Diuretics)
Arm/Group Description	Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Period Title: Overall Study
STARTED	18	19
COMPLETED	9	13
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	Ultrafiltration Group	Control Group (Usual Care IV Diuretics)	Total
Arm/Group Description	Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)	Total of all reporting groups
Overall Participants	18	19	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.5 (9.45)	74.2 (12.40)	72.9 (11)
Age, Customized (Count of Participants)
<45 years	0 0%	1 5.3%	1 2.7%
≥ 45 to <65 years	6 33.3%	2 10.5%	8 21.6%
≥65 years	12 66.7%	16 84.2%	28 75.7%
Sex: Female, Male (Count of Participants)
Female	3 16.7%	5 26.3%	8 21.6%
Male	15 83.3%	14 73.7%	29 78.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	18 100%	19 100%	37 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	173.4 (7.80)	172.3 (13.28)	172.8 (10.83)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	106.4 (33.17)	95.6 (27.42)	100.9 (30.42)
Body-Mass-Index (BMI) (Count of Participants)
≥18.5 to <25 kg/m^2	1 5.6%	4 21.1%	5 13.5%
≥25 to <30 kg/m^2	8 44.4%	4 21.1%	12 32.4%
≥30 to <35	1 5.6%	6 31.6%	7 18.9%
≥35 to <40 kg/m^2	2 11.1%	3 15.8%	5 13.5%
≥40 kg/m^2	6 33.3%	2 10.5%	8 21.6%
Systolic Blood Pressure (SBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	117.6 (26.23)	128.5 (29.84)	123.2 (28.30)
Diastolic Blood Pressure (DBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	68.4 (10.62)	70.4 (14.68)	69.4 (12.73)
Heart rate (bpm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [bpm]	73.2 (20.32)	71.9 (14.57)	72.5 (17.28)
New York Heart Association (NYHA) Functional Classification (Count of Participants)
NYHA I	0 0%	0 0%	0 0%
NYHA II	1 5.6%	0 0%	1 2.7%
NYHA III	14 77.8%	14 73.7%	28 75.7%
NYHA IV	2 11.1%	5 26.3%	7 18.9%
Missing	1 5.6%	0 0%	1 2.7%

Outcome Measures

1. Primary Outcome

Title	Heart Failure (HF) Event
Description	Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.
Time Frame	in 90 days after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrafiltration Group	Control Group (Usual Care IV Diuretics)
Arm/Group Description	Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Measure Participants	18	19
Count of Participants [Participants]	4 22.2%	4 21.1%

2. Primary Outcome

Title	Cardiovascular Death up to 90 Days After Randomization.
Description	The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after ~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes
Time Frame	in 90 days after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrafiltration Group	Control Group (Usual Care IV Diuretics)
Arm/Group Description	Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Measure Participants	18	19
Count of Participants [Participants]	4 22.2%	1 5.3%

Adverse Events

Time Frame	Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit.
Adverse Event Reporting Description	Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Arm/Group Title	Ultrafiltration Group		Control Group (Usual Care IV Diuretics)
Arm/Group Description	Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.		Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
All Cause Mortality
	Ultrafiltration Group		Control Group (Usual Care IV Diuretics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/18 (38.9%)		2/19 (10.5%)
Serious Adverse Events
	Ultrafiltration Group		Control Group (Usual Care IV Diuretics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/18 (83.3%)		13/19 (68.4%)
Cardiac disorders
Cardiac Failure	6/18 (33.3%)	6	4/19 (21.1%)	7
Atrioventricular	1/18 (5.6%)	1	0/19 (0%)	0
Cardiac failure	1/18 (5.6%)	1	0/19 (0%)	0
Cardiogenic shock	1/18 (5.6%)	1	0/19 (0%)	0
Cardiovascular	1/18 (5.6%)	1	0/19 (0%)	0
Sinoatrial block	1/18 (5.6%)	1	0/19 (0%)	0
Ventricular	0/18 (0%)	0	1/19 (5.3%)	1
Gastrointestinal disorders
Abdominal wall	1/18 (5.6%)	1	0/19 (0%)	0
General disorders
Death	2/18 (11.1%)	2	1/19 (5.3%)	1
Infections and infestations
Pneumonia	2/18 (11.1%)	2	0/19 (0%)	0
Erysipelas	1/18 (5.6%)	1	0/19 (0%)	0
Staphylococcal	1/18 (5.6%)	1	0/19 (0%)	0
Injury, poisoning and procedural complications
Contusion	0/18 (0%)	0	1/19 (5.3%)	1
Rib fracture	0/18 (0%)	0	1/19 (5.3%)	1
Vascular	1/18 (5.6%)	1	0/19 (0%)	0
Investigations
Echocardiogram	1/18 (5.6%)	1	0/19 (0%)	0
Oxygen saturation	1/18 (5.6%)	1	0/19 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/18 (5.6%)	1	0/19 (0%)	0
Fluid overload	1/18 (5.6%)	1	0/19 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	1/18 (5.6%)	1	0/19 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/18 (0%)	0	1/19 (5.3%)	1
Nervous system disorders
Dementia	0/18 (0%)	0	1/19 (5.3%)	1
Syncope	1/18 (5.6%)	1	0/19 (0%)	0
Product Issues
Device dislocation	1/18 (5.6%)	1	0/19 (0%)	0
Psychiatric disorders
Delirium	0/18 (0%)	0	1/19 (5.3%)	1
Suicide attempt	0/18 (0%)	0	1/19 (5.3%)	1
Renal and urinary disorders
Acute kidney	2/18 (11.1%)	2	2/19 (10.5%)	2
Renal failure	0/18 (0%)	0	2/19 (10.5%)	2
Nephrotic	1/18 (5.6%)	1	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/18 (5.6%)	1	0/19 (0%)	0
Social circumstances
Loss of personal	0/18 (0%)	0	1/19 (5.3%)	1
Surgical and medical procedures
Catheter	1/18 (5.6%)	1	0/19 (0%)	0
Stent placement	0/18 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Ultrafiltration Group		Control Group (Usual Care IV Diuretics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/18 (66.7%)		14/19 (73.7%)
Cardiac disorders
Cardiac failure	1/18 (5.6%)		4/19 (21.1%)
Atrial fibrillation	0/18 (0%)		1/19 (5.3%)
Bradycardia	0/18 (0%)		1/19 (5.3%)
Bundle branch block left	0/18 (0%)		1/19 (5.3%)
Cardiac failure congestive	1/18 (5.6%)		0/19 (0%)
Ear and labyrinth disorders
Vertigo	0/18 (0%)		1/19 (5.3%)
Gastrointestinal disorders
Nausea	1/18 (5.6%)		0/19 (0%)
General disorders
Oedema peripheral	2/18 (11.1%)		1/19 (5.3%)
Pyrexia	1/18 (5.6%)		2/19 (10.5%)
Cyst	0/18 (0%)		1/19 (5.3%)
Injection site pain	0/18 (0%)		1/19 (5.3%)
Therapeutic product ineffective	1/18 (5.6%)		0/19 (0%)
Vessel puncture site haematoma	1/18 (5.6%)		0/19 (0%)
Infections and infestations
Wound	1/18 (5.6%)		0/19 (0%)
Pneumonia	2/18 (11.1%)		1/19 (5.3%)
Escherichia infection	0/18 (0%)		1/19 (5.3%)
Escherichia urinary tract infection	0/18 (0%)		1/19 (5.3%)
Injury, poisoning and procedural complications
Fall	0/18 (0%)		1/19 (5.3%)
Post procedural haematoma	1/18 (5.6%)		0/19 (0%)
Skin laceration	0/18 (0%)		1/19 (5.3%)
Vascular access complication	1/18 (5.6%)		0/19 (0%)
Investigations
Blood creatinine increased	1/18 (5.6%)		0/19 (0%)
Glomerular filtration rate decreased	0/18 (0%)		1/19 (5.3%)
Haemoglobin decreased	0/18 (0%)		1/19 (5.3%)
Metabolism and nutrition disorders
Arthralgia	1/18 (5.6%)		1/19 (5.3%)
Back pain	2/18 (11.1%)		0/19 (0%)
Flank pain	1/18 (5.6%)		0/19 (0%)
Musculoskeletal pain	1/18 (5.6%)		0/19 (0%)
Pain in extremity	1/18 (5.6%)		0/19 (0%)
Nervous system disorders
Dementia	1/18 (5.6%)		1/19 (5.3%)
Dementia Alzheimer's type	0/18 (0%)		1/19 (5.3%)
Presyncope	0/18 (0%)		1/19 (5.3%)
Syncope	0/18 (0%)		1/19 (5.3%)
Product Issues
Needle issue	1/18 (5.6%)		0/19 (0%)
Psychiatric disorders
Delirium	1/18 (5.6%)		0/19 (0%)
Renal and urinary disorders
Renal failure	0/18 (0%)		3/19 (15.8%)
Chronic kidney disease	1/18 (5.6%)		1/19 (5.3%)
Haematuria	0/18 (0%)		1/19 (5.3%)
Urinary Incontinence	1/18 (5.6%)		0/19 (0%)
Urinary retention	0/18 (0%)		1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/18 (5.6%)		2/19 (10.5%)
Dyspnoea	1/18 (5.6%)		0/19 (0%)
Dyspnoea exertional	1/18 (5.6%)		0/19 (0%)
Emphysema	0/18 (0%)		1/19 (5.3%)
Haemothorax	0/18 (0%)		1/19 (5.3%)
Pulmonary hypertension	1/18 (5.6%)		0/19 (0%)
Tachypnoea	0/18 (0%)		1/19 (5.3%)
Skin and subcutaneous tissue disorders
Stasis dermatitis	1/18 (5.6%)		1/19 (5.3%)
Decubitis ulcer	1/18 (5.6%)		0/19 (0%)
Skin lesion	1/18 (5.6%)		0/19 (0%)
Skin ulcer	1/18 (5.6%)		0/19 (0%)
Surgical and medical procedures
Cardiac resynchronisation therapy	1/18 (5.6%)		0/19 (0%)
Cardioversion	1/18 (5.6%)		0/19 (0%)
Dialysis device insertion	1/18 (5.6%)		0/19 (0%)
Percutaneous coronary intervention	0/18 (0%)		1/19 (5.3%)
Vascular disorders
Hypotension	3/18 (16.7%)		2/19 (10.5%)
Haematoma	1/18 (5.6%)		0/19 (0%)
Peripheral arterial occlusive disease	1/18 (5.6%)		0/19 (0%)
Thrombophlebitis	1/18 (5.6%)		0/19 (0%)

Limitations/Caveats

Due to the premature termination of the study and a resulting sample size of 37 patients in both analyses sets no statistical testing for any study endpoint has been applied. All study objectives were analyzed purely descriptively, continuous data with sample statistics, categorical data by frequency tables.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.