Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03251183
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2017-05-14
Brief Title:
Validation of CMR Against Invasive Haemodynamics in Patients With HFpEF
Sponsor:
Goethe University
Organization:
Goethe University
Study Overview
Official Title:
Validation of Cardiovascular Magnetic Resonance Against Invasive Haemodynamics in Patients With Heart Failure With Preserved Ejection Fraction DECIPHER HFpEF
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIPHER-HFpEF
Brief Summary:
Heart failure HF currently affects app 2 of the western population and app 10 of people 75 years In about 50 of patients with symptomatic HF ejection fraction EF is preserved HF-PEF Once patients develop symptoms the prognosis is poor with 25 mortality at 1 year and 50 mortality at 5 years HFpEF is one of the major unresolved areas in clinical cardiology The diagnosis of HFpEF remains a diagnosis of exclusion and currently no non-invasive measure provides a clear diagnosis
Cardiovascular magnetic resonance CMR provides non invasive and radiation free evaluation of heart structure and function New CMR parameters offer the possibility to describe the underlying pathological and physiological changes associated with HFpEF
The investigators propose to undertake the first systematic comparison between a CMR protocol and invasive haemodynamics as the best possible gold standard as well as define the histopathological drivers in myocardial biopsies The investigators will also examine the relations with tissue and serological biomarkers implicated in HFpEF and the role with standard and novel parameters by echocardiography If successful this study will provide tools for a reliable and accurate non-invasive characterization of patients with HFpEF supporting the diagnosis and grading the severity of disease This study will provide a reference basis for future diagnostic algorithms in HFpEF both for CMR and echocardiography but also for their relative value in comparison to blood markers or invasive testing In addition to a new pathway to acess the effects of current and novel therapeutic interventions the investigators see the greatest potential in identifying a disease stage where the myocardial injury may be reversible
Cardiovascular magnetic resonance CMR provides non invasive and radiation free evaluation of heart structure and function New CMR parameters offer the possibility to describe the underlying pathological and physiological changes associated with HFpEF
The investigators propose to undertake the first systematic comparison between a CMR protocol and invasive haemodynamics as the best possible gold standard as well as define the histopathological drivers in myocardial biopsies The investigators will also examine the relations with tissue and serological biomarkers implicated in HFpEF and the role with standard and novel parameters by echocardiography If successful this study will provide tools for a reliable and accurate non-invasive characterization of patients with HFpEF supporting the diagnosis and grading the severity of disease This study will provide a reference basis for future diagnostic algorithms in HFpEF both for CMR and echocardiography but also for their relative value in comparison to blood markers or invasive testing In addition to a new pathway to acess the effects of current and novel therapeutic interventions the investigators see the greatest potential in identifying a disease stage where the myocardial injury may be reversible
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None