Back to resultsReducing Lung CongestIon Symptoms in Advanced Heart Failure (RELIEVE-HF)
Primary Purpose
Heart Failure
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
V-Wave Interatrial Shunt
Control
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Main Inclusion Criteria:
- Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
- NYHA Class II, Class III, or ambulatory Class IV HF
- Receiving guideline directed medical and device therapy (GDMT) for heart failure
- For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
- For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Main Exclusion Criteria:
- Systolic blood pressure <90 or >160 mmHg
- Presence of Intracardiac thrombus
- Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
- Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
- Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
- Moderate to severe aortic or mitral stenosis
- Stroke or TIA or DVT within the last 6 months
- eGFR <25 ml/min/1.73 m^2
- Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
- Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
- Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria
Sites / Locations
- Mercy Gilbert Medical Center
- Abrazo Arizona Heart Hospital
- Arizona Heart Rhythm Center
- Scripps Health
- Long Beach Memorial Medical Center
- Keck Medical Center of USC
- Cedars Sinai Medical Center
- Kaiser Permanente San Francisco
- University of California, San Francisco
- Stanford Hospital
- Los Robles Hospital & Medical Center
- The Lundquist Institute (Harbor-UCLA) Medical Center
- South Denver Cardiology
- Morton Plant Mease Healthcare
- Memorial Regional Hospital
- Memorial Hospital
- University of Miami
- First Coast Cardiovascular Institute
- Piedmont Hospital
- Atlanta VA Health System
- Northeast Georgia Medical Center
- Rush University Medical Center
- Advocate Illinois Masonic Medical Center
- Advocate Health and Hospitals Corporation (Edwards Hospital)
- St Elizabeth Medical Center
- United Heart & Vascular Clinic
- Nebraska Heart Institute
- Valley Health System
- St. Francis Hospital
- Weill Cornell
- Northwell Health Lenox Hill Hospital
- Rochester General Health System
- Mission Hospital
- North Carolina Heart & Vascular
- Wakemed
- Summa Health
- Lindner Center for Research and Education at The Christ Hospital
- Cleveland Clinic
- The Ohio State University
- Penn State Milton S. Hershey Medical Center
- UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
- Medical University of South Carolina
- Centennial Medical Center
- Vanderbilt University Medical Center
- Austin Heart
- Baylor College of Medicine
- Texas Heart Institute
- University of Texas Memorial Hermann
- Methodist Hospital
- Baylor Heart and Vascular-Dallas (Scott and White) -Temple
- Christus Mother Frances Hospital
- University of Utah Hospital
- University of Virginia
- Sentara Heart Hospital
- Chippenham Medical Center
- St. Vincent's Hospital Sydney
- Flinders Medical Centre
- Prince Charles Hospital
- St. Vincent's Hospital
- Epworth Hospital
- Antwerp Cardiovascular Center, ZNA Middelheim Hospital
- AZ Sint-Jan Brugge
- Toronto General Hospital
- Montréal Heart Institute
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
- Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
- Vivantes Klinikum im Friedrichshain
- Vivantes Klinikum Urban
- Marienkrankrankenhas
- Universitätsklinikum Leipzig
- Herzzentrum Leipzig
- Universitatsmedizin Mainz
- Ludwig-Maximilians-Universität München
- SANA Remscheid
- University of Rostock
- University Hospital Samson Assuta Ashdod
- Yitzhak Shamir Medical Center
- Soroka University Medical Center
- Rambam Medical Center
- Shaare Zedek Medical Center
- Hadassah Medical Center
- The Chaim Sheba Medical Center Tel-Hashomer
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center
- The Baruch Padeh Medical Center, Poriya
- St Antonius Ziekenhuis Nieuwegein
- Academic Medical Center, The Netherlands
- Erasmus University Medical Center Rotterdam
- Christchurch Hospital
- Auckland Hospital
- Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach
- Institute of Cardiology, Warsaw
- The 4th Military Clinical Hospital Wroclaw
- University Hospital Wroclaw
- Hospital Clinic of Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
- Hospital Clínico San Carlos
- Hospital Puerta de Hierro-Majadahonda
- University Hospital Virgen de la Arrixaca
- Hospital Clínico Universitario de Valencia
- Hospital Clínico Universitario de Valladolid
- Bern University Hospital
- University Hospital of Zürich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Experimental
Arm Label
Treatment
Control
Roll in
Arm Description
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Outcomes
Primary Outcome Measures
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Secondary Outcome Measures
6MWT changes
6MWT changes
KCCQ changes
KCCQ changes
KCCQ changes
KCCQ changes
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time to all-cause death or first heart failure hospitalization
Time to all-cause death or first heart failure hospitalization
Cumulative heart failure hospitalizations
Cumulative heart failure hospitalizations
Time to first heart failure hospitalization
Time to first heart failure hospitalization
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499236
Brief Title
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Acronym
RELIEVE-HF
Official Title
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
V-Wave Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Detailed Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 2 patients per site in an open-label study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.
Allocation
Randomized
Enrollment
605 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Arm Title
Control
Arm Type
Other
Arm Description
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.
Arm Title
Roll in
Arm Type
Experimental
Arm Description
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation
Intervention Type
Device
Intervention Name(s)
V-Wave Interatrial Shunt
Intervention Description
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Right heart catheterization, invasive echocardiography.
Primary Outcome Measure Information:
Title
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Description
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
Time Frame
30-days after randomization
Title
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Time Frame
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary Outcome Measure Information:
Title
6MWT changes
Description
6MWT changes
Time Frame
Baseline to 12 months
Title
KCCQ changes
Description
KCCQ changes
Time Frame
Baseline to 12 months
Title
KCCQ changes
Description
KCCQ changes
Time Frame
Baseline through study completion, maximum of five years
Title
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Description
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time Frame
Baseline through study completion, maximum of five years
Title
Time to all-cause death or first heart failure hospitalization
Description
Time to all-cause death or first heart failure hospitalization
Time Frame
Baseline through study completion, maximum of five years
Title
Cumulative heart failure hospitalizations
Description
Cumulative heart failure hospitalizations
Time Frame
Baseline through study completion, maximum of five years
Title
Time to first heart failure hospitalization
Description
Time to first heart failure hospitalization
Time Frame
Baseline through study completion, maximum of five years
Title
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Description
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Time Frame
Baseline through study completion, maximum of five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
NYHA Class II, Class III, or ambulatory Class IV HF
Receiving guideline directed medical and device therapy (GDMT) for heart failure
For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Main Exclusion Criteria:
Systolic blood pressure <90 or >160 mmHg
Presence of Intracardiac thrombus
Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
Moderate to severe aortic or mitral stenosis
Stroke or TIA or DVT within the last 6 months
eGFR <25 ml/min/1.73 m^2
Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan D Anker, MD, PhD
Organizational Affiliation
University Medical Center Gottingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JoAnn Lindenfeld, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josep Rodés-Cabau, MD
Organizational Affiliation
Université Laval (CRIUCPQ-ULaval)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregg W Stone, MD
Organizational Affiliation
Colombia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Abrazo Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Heart Rhythm Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
The Lundquist Institute (Harbor-UCLA) Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
South Denver Cardiology
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Morton Plant Mease Healthcare
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Atlanta VA Health System
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Advocate Health and Hospitals Corporation (Edwards Hospital)
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
St Elizabeth Medical Center
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
United Heart & Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Valley Health System
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
St. Francis Hospital
City
East Hills
State/Province
New York
ZIP/Postal Code
11548
Country
United States
Facility Name
Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Northwell Health Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Rochester General Health System
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
North Carolina Heart & Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wakemed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Summa Health
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Lindner Center for Research and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
80120
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Baylor Heart and Vascular-Dallas (Scott and White) -Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Christus Mother Frances Hospital
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Chippenham Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
Country
Australia
Facility Name
Prince Charles Hospital
City
Brisbane
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
Country
Australia
Facility Name
Epworth Hospital
City
Richmond
Country
Australia
Facility Name
Antwerp Cardiovascular Center, ZNA Middelheim Hospital
City
Antwerp
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
Country
Belgium
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Montréal Heart Institute
City
Montréal
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Vivantes Klinikum Urban
City
Berlin
Country
Germany
Facility Name
Marienkrankrankenhas
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitatsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Ludwig-Maximilians-Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
SANA Remscheid
City
Remscheid
Country
Germany
Facility Name
University of Rostock
City
Rostock
Country
Germany
Facility Name
University Hospital Samson Assuta Ashdod
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Yitzhak Shamir Medical Center
City
Be'er Ya'aqov
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31906
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
The Chaim Sheba Medical Center Tel-Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
The Baruch Padeh Medical Center, Poriya
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
St Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Academic Medical Center, The Netherlands
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Erasmus University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Auckland Hospital
City
Grafton
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Institute of Cardiology, Warsaw
City
Warszawa
Country
Poland
Facility Name
The 4th Military Clinical Hospital Wroclaw
City
Wrocław
Country
Poland
Facility Name
University Hospital Wroclaw
City
Wrocław
Country
Poland
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Puerta de Hierro-Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
University Hospital Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital of Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
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