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NCT Number: NCT06805253

Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.

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Key information

Conditions

Aortic Valve Regurgitation Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Diastolic Heart Failure Heart Diseases Heart Failure Heart Failure, Diastolic Heart Valve Diseases Left Atrium Dilated Left Ventricle Dilated Mitral Valve Insufficiency Mitral Valve Regurgitation Systolic Left Ventricular Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Petrovsky National Research Center of Surgery, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Planned primary elective surgery for chronic aortic regurgitation
  • Presence of functional mitral regurgitation
  • End-diastolic volume of the left ventricle >= 250 ml

Exclusion criteria

  • Infectious endocarditis
  • History of myocardial infarction
  • Indications on simultaneous myocardial revascularisation
  • Acute aortic regurgitation of any etiology
  • Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
  • Long-term persistent or permanent form of atrial fibrillation
  • Pregnancy in the first 12 months after surgery
  • Simultaneous participation in other studies
  • Presence of implanted pacemakers
  • Refusal to sign informed consent
  • Acute coronary event diagnosed within 12 months after aortic valve surgery
  • Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery
  • Re-do cardiac surgery for any reason within 12 months after aortic valve surgery

Treatment and study plan

Not applicable - observational study

Other

observation only

Other names: observation

Primary outcomes

  1. LV end-diastolic volume (EDV) decrease

    Time frame: 3 and 12 months after surgery

    Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency

  2. Freedom from readmission

    Time frame: 12 months after surgery

    Freedom from readmission due to valvular problem or heart failure-related reason

Secondary outcomes

  1. Life quality

    Time frame: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery

    The patient's life quality according to the results of the EuroQol-5D-5L (EQ-5D-5L) questionnaire (0-100 points, the higher - the better).

Other outcomes

  1. LV ejection fraction (EF)

    Time frame: 3 and 12 month post-surgery

    Left ventricle ejection fraction, assessed with EchoCG

  2. LV diastolic function

    Time frame: Upon inclusion, 3 month and 12 month post-surgery

    Left ventricle diastolic function, assessed with EchoCG

  3. Left atrium volume index (LAVI)

    Time frame: Upon inclusion, 3 month and 12 month post-surgery

    Left atrium volume indexed to body surface area, assessed with EchoCG

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Bulynin

CONTACT

[email protected]

+79081339584

Eduard Charchyan, professor

CONTACT

[email protected]

+79262174114

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Collaborators

  • Voronezh regional clinical hospital #1

Registry information

Official study title

Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment

Acronym: ORMIX

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Feb 3, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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