Heart Failure With Preserved Ejection FractionNCT06992089
SHort Of Pace - Heart Failure (SHOP-HF)
A study testing Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) in people with Heart Failure With Preserved Ejection Fraction, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2025to Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vicente Bertomeu, Doctor contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico de la Comunidad Valenciana
Valencia, 46010
Julio Núñez Villota
About this study
Official title: Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
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. The population includes patients with the diagnosis of stable HFpEF according to criteria of the European Society of Cardiology and New York Heart Association (NYHA) functional class II-III/IV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI).
All patients will undergo pacemaker implantation, and computer-generated randomization sequence previously designed will be used to allocate participants (in a 1:1 ratio) to receive: (a) programming of the pacemaker with pacing On followed by pacing Off in two periods of 3 months; or (b) programming of the pacemaker with pacing Off followed by pacing On in two periods of 3 months. The study will be conducted in three centers in Spain. Discounting the time due to staggered entry, the total duration of a patient's follow-up will be 7 months.
- Being tested
- Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)Device
Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), with rate-adaptive pacing of the right atrium. There will be an associated right atrial lead (INGEVITY™ MRI Pacing Lead Boston®) and right ventricular lead (INGEVITY™ MRI Pacing Lead Boston®).
Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®), with rate-adaptive pacing of the ventricles. There will be a right ventricular lead (INGEVITY™ MRI P Boston®).
| Study group | Role | What they receive |
|---|---|---|
| Pacing on | Experimental | Pacemarker stimulation programmed as AAIR / DDDR / VVIR with the basic stimulation frequency and the rate response as follows (pacing on):
* Basic heart rate: derived from the averaged resting heart rates of healthy adults according to height and LVEF.
* Rate response through a combination of minute ventilation and accelerometer: with a response factor of 3 and a medium-low activity threshold. Receives: Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) |
| Pacing off | Placebo comparator | VVI 30 bpm Receives: Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.
Measured: 3 months after the pacemarker stimulation
Secondary outcomes (6)
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: From randomization until the end of study in month 7
E/E' ratio
Absolute changes in echocardiogram parameters (E/E' ratio)
Measured: From baseline until the end of study in month 7
Left ventricular volume index
Absolute changes in echocardiogram parameters (Left ventricular volume index)
Measured: From baseline until the end of study in month 7
Left atrial volume index
Absolute changes in echocardiogram parameters (Left atrial volume index)
Measured: From baseline until the end of study in month 7
Pro-B-type natriuretic peptide
Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)
Measured: From baseline until the end of study in month 7
Serum carbohydrate antigen 125
Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).
Measured: From baseline until the end of study in month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start17 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Núñez, Doctor, Principal investigator, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992089
- Sponsor's protocol ID
- SHOP-HF
- Status last verified
- Dec 2025
- First submitted
- 9 May 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
- ClinicalTrials.gov ID
- NCT06992089
- Acronym / sponsor ID
- SHOP-HF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 28 May 2025 (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.
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. The population includes patients with the diagnosis of stable HFpEF according to criteria of the European Society of Cardiology and New York Heart Association (NYHA) functional class II-III/IV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI).
All patients will undergo pacemaker implantation, and computer-generated randomization sequence previously designed will be used to allocate participants (in a 1:1 ratio) to receive: (a) programming of the pacemaker with pacing On followed by pacing Off in two periods of 3 months; or (b) programming of the pacemaker with pacing Off followed by pacing On in two periods of 3 months. The study will be conducted in three centers in Spain. Discounting the time due to staggered entry, the total duration of a patient's follow-up will be 7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacing on | Experimental | Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)Pacemarker stimulation programmed as AAIR / DDDR / VVIR with the basic stimulation frequency and the rate response as follows (pacing on): * Basic heart rate: derived from the averaged resting heart rates of healthy adults according to height and LVEF. * Rate response through a combination of minute ventilation and accelerometer: with a response factor of 3 and a medium-low activity threshold. |
| Pacing off | Placebo comparator | Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)VVI 30 bpm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
- Diagnosis criteria of HFpEF according to ESC guidelines:
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), with rate-adaptive pacing of the right atrium. There will be an associated right atrial lead (INGEVITY™ MRI Pacing Lead Boston®) and right ventricular lead (INGEVITY™ MRI Pacing Lead Boston®). Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®), with rate-adaptive pacing of the ventricles. There will be a right ventricular lead (INGEVITY™ MRI P Boston®). | Device | Pacing off, Pacing on |
Primary outcome
Peak oxygen uptake
Time frame: 3 months after the pacemarker stimulation
The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.
6 secondary outcomes
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: From randomization until the end of study in month 7
E/E' ratio
Time frame: From baseline until the end of study in month 7
Left ventricular volume index
Time frame: From baseline until the end of study in month 7
Left atrial volume index
Time frame: From baseline until the end of study in month 7
Pro-B-type natriuretic peptide
Time frame: From baseline until the end of study in month 7
Serum carbohydrate antigen 125
Time frame: From baseline until the end of study in month 7
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 12 Dec 2025.
- 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.
Vicente Bertomeu, Doctor contact
Julio Núñez, Doctor principal investigator
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) in people with Heart Failure With Preserved Ejection Fraction, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 13 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 12 Dec 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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 Julio Núñez, Doctor (652856689, yulnunez@gmail.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: 3 months after the pacemarker stimulation). 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 12 Dec 2025.