Phosphodiesterase-5 inhibition in patients with heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension (PASSION)

Overview
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A randomized, placebo-controlled, double-blind, parallel group, multi-center, phase III trial to address treatment options for combined post- and pre-capillary pulmonary hypertension and heart failure with preserved ejection fraction

Sponsor: Philipps-University Marburg

SEEK ID: https://ldh.kks-marburg.imise.uni-leipzig.de/projects/2

Funding codes:

BMBF

Public web page: Not specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 20th Jun 2020

Trial Project end date: 30th Jun 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : 29556

Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : A randomized, placebo-controlled, double-blind, parallel group, multi-center, phase III trial to address treatment options for combined post- and pre-capillary pulmonary hypertension and heart failure with preserved ejection fraction
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : PASSION
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : Globally and locally, CpcPH-HFpEF is the most common form of PH. This disease is associated with a high morbidity and mortality, but effective treatments are not yet available. Therefore we propose this study to assess the long-term safety and efficacy of tadalafil, a phosphodiesterase-5 (PDE5) inhibitor in patients with combined post- and pre-capillary pulmonary hypertension (PH) due to heart failure with preserved ejection fraction (CpcPHHFpEF). The primary objective will be the composite of all-cause mortality and heart failure-related hospitalizations (adjudicated). Key secondary endpoints include safety, exercise capacity and quality of life.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : phosphodiesterase-5 (PDE5)

Keyword(*) : pulmonary hypertension (PH)

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : 01KG1712
Name of the organisation/institution/group(*) : Phillips-University Marburg/KKS Marburg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : info@kks.uni-marburg.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Philipps-University Marburg - KKS Marburg
Address : Karl-von-Frisch-Str. 4, 35043 Marburg
Web page : https://www.kks.uni-marburg.de
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2017-003688-37

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Pulmonary Hypertension
Terminology/classification(*) : ICD-10
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the respiratory system (X)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume
Participants enrolled by invitation? : No
Start date : 12 March 2019
End date : 30 June 2023
Mono- or multicentric? : Multicentric
Number of centers : 23
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : Male, Female
Inclusion criteria : see protocol
Exclusion criteria : see protocol
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : phosphodiesterase-5 inhibitor tadalafil
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Verum
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Event-free survival
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Investigator
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Yes

Annotated Properties

Topic annotations

Preclinical and clinical studies

Phosphodiesterase-5 inhibition in patients with heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension (PASSION)

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