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New treatment option for HFpEF
Official title Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT07270536
What this study is testing
- What it's testing
- What is HFpEF? In heart failure with preserved ejection fraction (HFpEF), the heart pumps well but struggles to relax and fill with blood between beats.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Heart failure with preserved ejection fraction, defined as one of the below criteria:
- EF \>= 45% and HFA-PEFF score \>= 5 (Heart Failure Association-Pre-test assessment, Echocardiography and natriuretic peptide, Functional testing...
See the full eligibility criteria
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Heart failure with preserved ejection fraction, defined as one of the below criteria:
- EF \>= 45% and HFA-PEFF score \>= 5 (Heart Failure Association-Pre-test assessment, Echocardiography and natriuretic peptide, Functional testing, Final etiology; heart failure association of the European Society of...
- EF \>= 45% and H2FPEF score \>= 6 (Heavy, Hypertensive, Atrial fibrillation, Pulmonary hypertension, Elder, Filling pressure; Mayo Clinic group (35)))
- EF \>= 45% and i. History of heart failure hospitalization after pacemaker implantation or ii.On loop-diuretics at time of inclusion
- Having a DDD-pacemaker with LBB area pacing, implanted at least 12 weeks before iCPET
- \>=6 weeks on optimal HFpEF therapy (MRA and SGLT2i) at time of iCPET, unless contraindicated or not tolerated
- Sinus rhythm at time of screening and iCPET Participants eligible for this Study must not meet any of the following criteria:
- Participant has a history of:
- Evidence of significant pulmonary comorbidity based on abnormal pulmonary function tests (FEV1 \<60%) or aberrant lung parenchyma more than mild on radiological imaging
- Severe/symptomatic valvular diseases
- Severe pulmonary hypertension (PASP \> 55mmHg estimated by Doppler Echo)
- Unstable arrhythmias (VT, VF)
- Recurrent syncopes after pacemaker implantation
- Permanent atrial fibrillation
- Amyloid cardiomyopathy
- Physical inability to perform exercise
- More than 1 hospitalization for heart failure in the last year
- Resting heart rate\> 100bpm
- At time of iCPET or inclusion: decompensated heart failure, unstable coronary syndrome
- Contraindication to central venous access
- Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL)
- Local infection or skin infection at the insertion site
- Thrombosis or anatomical abnormalities of the right jugular vein
- Pneumothorax or contralateral lung pathology
- Inability to properly position the patient
- Contraindication to arterial access
- Thrombosis or occlusion of the target artery
- Raynaud's phenomenon or other vasospastic disorders
- Active infection at the intended insertion site
- Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL)
- Insufficient collateral circulation (e.g., inadequate perfusion in an Allen test)
- Contraindications to CPET
- ECG signifying myocardial injury
- ECG signifying current or potentially lethal arrhythmias
- Systemic hypotension (e.g. systolic blood pressure \< 90 mmHg)
- Extreme hypertension (e.g. systolic blood pressure \> 220 mmHg)
- Syncope, presyncope, or lightheadedness
- SaO2 \< 88%
- Severely elevated PCWP (\> 40 mmHg) during exercise
The study team makes the final eligibility decision.
Where it's taking place
- Hasselt, Belgium
- Leuven, Belgium
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hasselt, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.