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NCT05575557
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
NA trial testing Right heart catheterization in Heart Failure With Reduced Ejection Fraction in 100 participants. Status unknown.
1 April 2024
Quick facts
| Lead sponsor | Shanghai 10th People's Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 November 2022 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 April 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Right heart catheterization
Conditions studied
- Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →
- Atrial Fibrillation, Persistent — all drugs for Atrial Fibrillation, Persistent →
- Sick Sinus Syndrome — all drugs for Sick Sinus Syndrome →
- Atrioventricular Block — all drugs for Atrioventricular Block →
Sponsor
Shanghai 10th People's Hospital
Who can join
Adults 18 to 99, any sex, with Heart Failure With Reduced Ejection Fraction or Atrial Fibrillation, Persistent. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP. At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05575557
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Related trials
Other trials of Right heart catheterization
Trials testing the same drug.
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- NCT06023134 — Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure · active not recruiting
Other recruiting trials for Heart Failure With Reduced Ejection Fraction
Currently open trials in the same condition.
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- NCT06942221 — Digital Solutions in Heart Therapy (DIGNITY) · NA · recruiting
- NCT07087613 — Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · recruiting
Other Shanghai 10th People's Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05575557 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai 10th People's Hospital
- Last refreshed: 29 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05575557.
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