Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05479669
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-07-19
Brief Title:
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-05
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:
VIP-HF2
Brief Summary:
Heart failure HF with a left ventricular ejection fraction LVEF 040 is a large medical problem for which no drug or device has a recommendation in current HF guidelines The prevalence of mortality and HF hospitalizations in HF with LVEF 040 is high but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors imaging parameters and circulating biomarkers and that these factors can be used in a risk profile
Detailed Description:
Objective To assess the risk profile associated with the combined endpoint of all-cause mortality and HF hospitalizations in HF patients with LVEF 040
Study design Single-center prospective study
Study population We aim 200 patients with symptomatic heart failure NYHA class II-III and a recent HF hospitalization emergency room visit or symptom relief with diuretics who have a left ventricular ejection fraction 040 echocardiographic evidence of left atrial enlargement or left ventricular hypertrophy and elevated concentrations of BNP or NT-proBNP
Study procedures All patients will undergo echocardiography cardiac magnetic resonance CMR imaging Holter recording and blood sampling at inclusion The 99mTc-HDP scan is optionalThere is no control group
Total follow up Up to five years
Main study endpoint incidence of the combined endpoint of all-cause mortality and HF hospitalizations
Study design Single-center prospective study
Study population We aim 200 patients with symptomatic heart failure NYHA class II-III and a recent HF hospitalization emergency room visit or symptom relief with diuretics who have a left ventricular ejection fraction 040 echocardiographic evidence of left atrial enlargement or left ventricular hypertrophy and elevated concentrations of BNP or NT-proBNP
Study procedures All patients will undergo echocardiography cardiac magnetic resonance CMR imaging Holter recording and blood sampling at inclusion The 99mTc-HDP scan is optionalThere is no control group
Total follow up Up to five years
Main study endpoint incidence of the combined endpoint of all-cause mortality and HF hospitalizations
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