Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

NCT05479669 | Recruiting

• 1 other identifier: VIP-HF 2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure, Diastolic

Keywords

heart failure with preserved ejection fraction; HFpEF; cardiac MRI; 99mTc-HDP scan

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of all-cause mortality and hospitalization for heart failure

  The incidence of the combined endpoint of all-cause mortality and first heart failure hospitalization

  5 years

Interventions

Echocardiography DIAGNOSTIC_TEST

Transthoracic echocardiograms will be performed at inclusion. Echocardiographic parameters that will be evaluated are measures of atrial size (including left atrial volume, right atrial dimensions, left ventricular function and dimensions (including left ventricular dimensions, septal wall thickness, posterior wall thickness, systolic function, Simpson biplane left ventricular ejection fraction), parameters of diastolic dysfunction (including E, A, E/A ratio, deceleration time, E' and E/E' ratio) and valve (dys)function.

24 hour Holter monitoring DIAGNOSTIC_TEST

24-hours Holter monitoring will be used to determine markers of increased risk of ventricular arrhythmias, such as non-sustained ventricular tachycardias, and ventricular premature beats and doublets. Also the presence and pattern of AF and runs of supraventricular tachycardias are determined.

Cardiac Magnetic Resonance Imaging DIAGNOSTIC_TEST

Multiple short-axis cine images will be acquired throughout the entire LV with a steady-state free precession sequence. Left ventricular volumes, ejection fraction and myocardial mass will be measured on the short-axis stacks at end diastolic and end systolic frames. Ten to 15 minutes after an intravenous bolus injection of a gadolinium-based contrast agent late gadolinium enhancement will be performed with a segmented inversion recovery gradient-echo sequence, using the same image orientation as in the short-axis stacks. The presence, location and morphology of myocardial fibrosis will be described. The extent of myocardial scar will be quantified using computer-assisted planimetry and expressed as a percentage of left ventricular mass. Pre- and post-contrast T1 measurements will be obtained using a single-shot modified Look Locker inversion recovery sequence. Extracellular volume (a measure of diffuse myocardial fibrosis) will be quantified.

99mTc-HDP scan DIAGNOSTIC_TEST

Patients will receive a 99mTc-HDP scan. 3 hours after the technetium 99m-hydroxymethylene diphosphonate bolus injection, imaging will be performed using a gamma-camera equipped with a collimator which guides individual gamma-rays emitted by the radionuclide. For planar imaging, a collimator will be used to transfer only those gamma-rays which pas in a perpendicular course. Sequentially, a SPECT-CT will be performed in the same session to improve sensitivity. SPECT/CT will be performed on a SPECT/CT dual head gamma camera system. SPECT images will be acquired using a 128 x 128 matrix, 180 degrees of rotation, 64 views, 15s per view. Visual image analysis will be performed by two blinded and experienced nuclear medicine physicians. Data will be scored according to a routine scoring system on a scale from 0 (no cardiac uptake of 99m technetium and normal bone uptake) to 3 (high cardiac uptake, higher than bone uptake).

ECG DIAGNOSTIC_TEST

A 12-lead electrocardiogram will be performed at the 1-year and 2-year follow-up visit to determine the heart rhythm and heart rate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To avoid the inclusion of patients with dyspnea due to other causes, we use specific (see below) echocardiographic and biomarker criteria. From several studies is known that in patients with HF with LVEF \>0.40 or AF, NT-proBNP or BNP is strongly associated with mortality an HF hospitalizations. The use of biomarker criteria will therefore help to select patients with an increased mortality risk. Therefore, by selecting HF patients with LVEF \>0.40 with a previous HF hospitalization we aim to include patients at increased risk for mortality and HF hospitalizations.

You may qualify if:

• Clinical criteria:
• Age \>18 years
• Written informed consent
• HF with moderate to severe symptoms NYHA II or III
• Hospitalization or emergency room visit for HF or symptom relief with diuretics
• Sinus rhythm or AF
• Echocardiographic criteria:
• LVEF \>0.40
• 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:
• BNP \>31ng/L or NT-pro-BNP\>125ng/L if sinus rhythm
• BNP \>75ng/L or NT-pro-BNP\>300ng/L if atrial fibrillation

You may not qualify if:

• Patients unwilling or unable to sign informed consent
• Patients with a pacemaker or ICD
• Indication for ICD therapy according to the ESC guidelines
• Life expectancy of less than one year
• Significant coronary artery disease or myocardial infarction \< 3 months
• Complex congenital heart disease
• Pregnancy

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Echocardiography; Electrocardiography, Ambulatory; Electrocardiography

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Michiel Rienstra, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel Rienstra, MD PhD

CONTACT

0031503612878; m.rienstra@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 29, 2022
• Study Start: March 29, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)