To study the incidence of 'sustained' ventricular tachyarrhythmias in patients with HFpEF.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective (efficacy) is to assess the incidence of sustained
ventricular tachyarrhythmias.
Secondary outcome
1. To assess the incidence of all cause mortality, cardiovascular mortality,
and sudden cardiac death
2. To assess the incidence of ICD-related complications
3. To assess the incidence of non-sustained tachyarrhythmias or slow
ventricular arrhythmias
4. To assess the incidence and burden of AF
5. To assess biomarkers (including echocardiography, 6 minute walk test, ECG
and other arrhythmogenic markers and blood biomarkers) for adequate ICD
therapies
6. To assess biomarkers (including echocardiography, 6 minute walk test, ECG
and other arrhythmogenic markers and blood biomarkers) for inadequate ICD
therapies
7. To assess biomarkers (including echocardiography, 6 minute walk test, ECG
and other arrhythmogenic markers and blood biomarkers) for development of
atrial or ventricular arrhythmias
8. To assess biomarkers (including echocardiography, 6 minute walk test, ECG
and other arrhythmogenic markers and blood biomarkers) for development of HF
hospitalizations and mortality
9. To assess the relation between cardiac amyloid deposition and other
biomarkers (including ECG, 6 minute walk test, Holter, echocardiography, CMR
and blood biomarkers) and incidence of sustained ventricular tachyarrhythmias,
incidence of atrial fibrillation, and development of HF hospitalizations,
sudden death, arrhythmic death, and all-cause mortality
Background summary
Heart failure with preserved ejection fraction (HFpEF) is a large medical
problem, for which no drug or device has a recommendation in current HF
guidelines. Sudden cardiac death is probably the most common cause of death in
HFpEF patients. Use of an Implantable Cardioverter Defibrillator (ICD) may be
useful in some patients with HFpEF. The VIP-HF registry aims to evualate the
possible utility of ICD therapy in HFpEF.
Study objective
To study the incidence of 'sustained' ventricular tachyarrhythmias in patients
with HFpEF.
Study design
Multicenter, prospective, non-randomized, intervention study.
Intervention
ICD implantation.
Study burden and risks
The present study may render important insights into the incidence of sustained
ventricular tachyarrhythmias in patients with HFpEF. Present observational
study may help to increase the knowledge on the incidence of life-threatening
ventricular tachyarrhythmias and therefore provide insight into sudden cardiac
death in patients with HFpEF. Eventually, this may lead to improved risk
stratification, therapeutic choices (ICD implant) and hence patient-tailored
therapy. At present no drug or device therapy has been proven beneficial in
patients with HFpEF. Currently, the ESC guidelines do not recommend ICD
implantation in the present study population.
In all patients an ILR will be implanted, which is associated with some
peri-procedural risks: infection and bleeding (risk < 1%). These complications
are rarely life-threatening. Patients will be informed in detail about the
risks. Blood sampling (24.5 cc each) occurs during vena punctures performed for
usual care, however, present study requires 3 additional vena punctures
(inclusion, after 12 months and 24 months of follow up). Risks of a vena
puncture are very slight and include excessive bleeding, fainting or feeling
light-headed, hematoma, local infection. Obtaining a blood sample from some
people may be more difficult than from others.
The usage of positron emitting isotopes in the 99m technetium scan translates
to an exposure to ionizing radiation. Because of the potential hazards of
radiation exposure, guidelines for the exposure of healthy volunteers are laid
down in *Besluit stralingsbescherming, artikel 60, staatblad 2001, 397* in
accordance with the guidelines of the International Commission on Radiological
Protection (ICRP). The radiation dose of 99mTc-HDP is 0.0057 mSv/MBq for
adults. Patients will receive a total dose of 700 MBq IV, which translates to a
total radiation dose of ± 3.99 mSv for the 99mTc-HDP scan. The radiation of a
low dose CT is approximately 1.5 mSv, which totals to a dose of 5.49 mSv
combined with the 99mTc-HDP scan. This complies with category IIb, ICRP 62. The
radation dose is calculated by our local clinical physicist. There are no other
study-related procedures required.
There are no other study-related procedures required. VIP-HF registry patients
will be implanted with a cardiac monitor. The total incidence of
peri-procedural complications is < 1% in experienced centers.
Catharijnesingel 52
Utrecht 3511 GC
NL
Catharijnesingel 52
Utrecht 3511 GC
NL
Listed location countries
Age
Inclusion criteria
Clinical criteria:
1. Age >18 years
2. Written informed consent
3. HF with moderate to severe symptoms NYHA II or III
4. Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months
5. Sinus rhythm or AF with adequate rate control (exercise test: maximum heart rate <160 bpm) ;Echocardiographic criteria:
1. LVEF >40%
2. Left atrial size (volume *34 mL/m2 or LA parasternal diameter *45 or left ventricular hypertrophy (septal thickness or posterior wall thickness *11 mm) of left ventricular diastolic dysfunction (E/e* *13 or mean e* septal and lateral wall <9 cm/s).;Biomarker criteria:
1. BNP >75ng/L or NT-pro-BNP>300ng/L if sinus rhythm
2. BNP >225ng/L or NT-pro-BNP>900ng/L if atrial fibrillation
Exclusion criteria
1. Patients unwilling or unable to sign informed consent
2. Patients with a pacemaker or ICD
3. Indication for ICD therapy according to the European Society of Cardiology (ESC) guidelines
4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction < 3 months
6. Complex congenital heart disease
7. Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01989299 |
| CCMO | NL47026.042.13 |