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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title SHort Of Pace - Heart Failure (SHOP-HF)
ClinicalTrials.gov ID: NCT06992089
What this study is testing
- What it's testing
- This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device . The crossover trial will be performed in a blind fashion, so each participant will be evaluated during both blinded pacing-on and pacing-off phases, each of which will last 3 months.
- Time commitment: about 3 months
- Which group you join is decided by chance.
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
- Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
- Diagnosis criteria of HFpEF according to ESC guidelines:
- symptoms and signs of HF.
- left ventricular ejection fraction ≥50% by Simpson method.
- proBNP \>125 pg/mL in the last month.
You likely can't join if
- Inability to perform a valid baseline exercise test.
- Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive...
- Patient with prior history of left ventricular ejection fraction \<50%.
- History of an acute coronary syndrome in the previous 12 months.
- Effort angina or signs of ischemia during CPET.
- RER threshold at \<1.05 at the CPET.
See the full eligibility criteria
- Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
- Diagnosis criteria of HFpEF according to ESC guidelines:
- symptoms and signs of HF.
- left ventricular ejection fraction ≥50% by Simpson method.
- proBNP \>125 pg/mL in the last month.
- at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement); and/or 2. Diastolic dysfunction.
- Left ventricular hypertrophy was defined as wall thickness \> 10 mm.
- Small ventricular volume was defined as indexed left ventricular end diastolic volume \< 45 ml/m2.
- Adults ≥18 years old.
- Previous admission for acute heart failure.
- Chronotropic incompetence assessed by CPET, defined as: [(HRmax - HRrest)]/[(220 - age) - (HRrest)] \< 0.62.
- Resting heart rate \< 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.
- Inability to perform a valid baseline exercise test.
- Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.
- Patient with prior history of left ventricular ejection fraction \<50%.
- History of an acute coronary syndrome in the previous 12 months.
- Effort angina or signs of ischemia during CPET.
- RER threshold at \<1.05 at the CPET.
- Significant primary moderate to severe valvular disease.
- Any other comorbidity with a life expectancy lower than 1 year.
- Heart rate at rest \> 75 lpm.
- Other pacemaker indication.
- Pregnant women.
- Baseline rhythm different from sinus rhythm or atrial fibrillation.
- Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Spain
Compensation & support
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 study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Valencia, Spain. 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.