---
title: SHort Of Pace - Heart Failure (SHOP-HF)
nct_id: NCT06992089
overall_status: RECRUITING
phase: NA
sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
study_type: INTERVENTIONAL
primary_condition: Heart Failure With Preserved Ejection Fraction
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06992089.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06992089"
ct_last_update_post_date: 2025-12-12
last_seen_at: "2026-05-12T06:50:35.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SHort Of Pace - Heart Failure (SHOP-HF)

**Official Title:** Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial

**NCT ID:** [NCT06992089](https://clinicaltrials.gov/study/NCT06992089)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Fundación para la Investigación del Hospital Clínico de Valencia
- **Conditions:** Heart Failure With Preserved Ejection Fraction
- **Start Date:** 2025-06-17
- **Completion Date:** 2026-06
- **CT.gov Last Update:** 2025-12-12

## Brief 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 . 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
* Diagnosis criteria of HFpEF according to ESC guidelines:

  1. symptoms and signs of HF.
  2. left ventricular ejection fraction ≥50% by Simpson method.
  3. proBNP \>125 pg/mL in the last month.
  4. 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.

Exclusion Criteria:

* 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.
```

## Arms

- **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.
- **Pacing off** (PLACEBO_COMPARATOR) — VVI 30 bpm

## Interventions

- **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®).

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- Hospital Clínico de la Comunidad Valenciana, Valencia, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital clínico de la comunidad valenciana|valencia||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06992089.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06992089*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*