VIP-HF2: Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
Study Details
Study Description
Brief Summary
Heart failure (HF) with a left ventricular ejection fraction (LVEF) >0.40 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 >0.40 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
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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 >0.40.
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 >0.40, 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 optional.There 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
Outcome Measures
Primary Outcome Measures
- Combined endpoint of all-cause mortality and hospitalization for heart failure [5 years]
The incidence of the combined endpoint of all-cause mortality and first heart failure hospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
Clinical criteria:
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Age >18 years
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Written informed consent
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HF with moderate to severe symptoms NYHA II or III
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Hospitalization or emergency room visit for HF or symptom relief with diuretics
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Sinus rhythm or AF
Echocardiographic criteria:
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LVEF >0.40
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Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s).
Biomarker criteria:
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BNP >31ng/L or NT-pro-BNP>125ng/L if sinus rhythm
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BNP >75ng/L or NT-pro-BNP>300ng/L if atrial fibrillation
Exclusion Criteria:
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Patients unwilling or unable to sign informed consent
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Patients with a pacemaker or ICD
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Indication for ICD therapy according to the ESC guidelines
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Life expectancy of less than one year
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Significant coronary artery disease or myocardial infarction < 3 months
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Complex congenital heart disease
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Michiel Rienstra, MD PhD, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIP-HF 2