Heart Failure, DiastolicVIP-HF2NCT05479669
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, Diastolic, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Echocardiography, 24 hour Holter monitoring and Cardiac Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Mar 2022to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Michiel Rienstra, MD PhD, 0031503612878, m.rienstra@umcg.nl
About this study
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
Read the 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.
- Conditions
- Heart Failure, Diastolic
- Being tested
- Echocardiography, 24 hour Holter monitoring, Cardiac Magnetic Resonance Imaging, 99mTc-HDP scan, ECG
- Keywords
- heart failure with preserved ejection fraction, HFpEF, cardiac MRI, 99mTc-HDP scan
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic 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 monitoringDiagnostic 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 ImagingDiagnostic 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 scanDiagnostic 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).
ECGDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start29 Mar 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel Rienstra, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479669
- Sponsor's protocol ID
- VIP-HF 2
- Acronym
- VIP-HF2
- Status last verified
- May 2024
- First submitted
- 19 Jul 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05479669
- Acronym / sponsor ID
- VIP-HF2 / VIP-HF 2
- Conditions
- Heart Failure, Diastolic
- Keywords
- heart failure with preserved ejection fraction, HFpEF, cardiac MRI, 99mTc-HDP scan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyTransthoracic 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. | Diagnostic test | – |
| 24 hour Holter monitoring24-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. | Diagnostic test | – |
| Cardiac Magnetic Resonance ImagingMultiple 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. | Diagnostic test | – |
| 99mTc-HDP scanPatients 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). | Diagnostic test | – |
| ECGA 12-lead electrocardiogram will be performed at the 1-year and 2-year follow-up visit to determine the heart rhythm and heart rate. | Diagnostic test | – |
Primary outcome
Combined endpoint of all-cause mortality and hospitalization for heart failure
Time frame: 5 years
The incidence of the combined endpoint of all-cause mortality and first heart failure hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michiel Rienstra, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Diastolic, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michiel Rienstra, MD PhD (0031503612878, m.rienstra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of all-cause mortality and hospitalization for heart failure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.