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Trabeculectomy for Improving Diastolic Function in Heart Failure with Preserved Ejection Fraction: A Phase I and II Clinical Trial

Trabeculectomy lmproves Diastolic Function in Heart Failure with Preserved Ejection Fraction

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112536
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-17
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure with Preserved Ejection Fraction

Interventions

Surgical Intervention Group:Patients will undergo the standard Morrow procedure combined with concurrent subvalvular trabecular resection and release.
Surgical Control Group:Patients will undergo the standard Morrow procedure without any further subvalvular intervention.
Medical Control Group:Patients will receive standard medical therapy only, without any surgical intervention.

Sponsors

Fuwai Hospital, Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years, possessing full civil capacity, and able to understand and sign the informed consent form; (2) Diagnosed with hypertrophic cardiomyopathy (HCM) and presenting with clear evidence of left ventricular outflow tract (LVOT) obstruction; (3) Diastolic dysfunction indicated by echocardiography and/or cardiac magnetic resonance (CMR) imaging; (4) No prior history of the Morrow procedure or any other interventional therapy that alters the left ventricular trabecular structure; (5) Deemed suitable for and recommended to receive either conservative medical therapy or surgical treatment following clinical evaluation, and willing to undergo follow-up according to the assigned treatment plan; (6) Willing to comply with the study protocol, including cooperating with pre-operative assessments, the treatment itself, and post-operative/follow-up examinations.

Exclusion criteria

Exclusion criteria: Patients presenting with any of the following conditions will be excluded from participation in this study: (1) Presence of severe concomitant diseases (e.g., active malignant tumor, end-stage hepatic or renal dysfunction, etc.); (2) Having previously undergone or scheduled to receive, during the study period, other interventional therapies that may affect cardiac structure and function (e.g., alcohol septal ablation, pacemaker implantation, etc.); (3) Pregnancy or lactation, or planning to become pregnant during the study period; (4) Any other condition deemed by the investigators to potentially compromise the interpretation of the study results.

Design outcomes

Primary

MeasureTime frame
E/e' ratio;

Secondary

MeasureTime frame
Changes in cardiac biochemical markers: including levels of biomarkers such as NT-proBNP, cTnI, and CK-MB.;Improvement in clinical symptoms;Parameters of cardiac structure and function: including Left Ventricular End-Diastolic Volume (LVEDV), Global Longitudinal Strain (GLS), and diastolic rate.;Electrocardiographic parameters: including the QT interval, cardiac rhythm, and conduction characteristics;

Countries

China

Contacts

Public ContactJiangping Song

Fuwai Hospital, Chinese Academy of Medical Science

fwsongjiangping@126.com+86 137 0135 5124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026