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Mitochondrial and Metabolic Mechanisms of Branched-Chain Amino Acid Metabolism Disorders Involved in the Development of Heart Failure with Preserved Ejection Fraction Research Program

Mitochondrial and Metabolic Mechanisms of Branched-Chain Amino Acid Metabolism Disorders Involved in the Development of Heart Failure with Preserved Ejection Fraction Research Program

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078563
Enrollment
Unknown
Registered
2023-12-12
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-19

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

HFpEF group :None
Control:None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1, Age = 60 years old 2, Signed informed consent 3, No new initiation or discontinuation of any of the following drugs in the previous 30-day regimen: ACEI, ARB, ß-blocker, CCB, and aldosterone antagonist. And no more than 100% dose adjustment of the above medications. 4. Symptoms of dyspnea (NYHA class II-IV) are present and the symptoms of dyspnea cannot be explained by non-cardiac or ischemic evidence 5. HF is the primary factor limiting activity 6. EF =50% as determined by imaging and current clinical status showing no potential for deterioration of systolic function 7, No continuous nitrate therapy or infrequent (less than 1 time/week) intermittent sublingual nitroglycerin administration in the past 3 months 8, One of the following conditions in the past 12 months: (1) NT-proBNP> 400 pg/ml or BNP> 200 pg/ml. (2) Past admission for HF with imaging evidence of pulmonary hemorrhage (pulmonary hypertension, vascular obstruction, interstitial edema, pleural effusion). (3) LVEDP =15 mmHg or PCWP =20 mmHg at rest or PCWP =25 mmHg during exercise measured by catheterization. (4) Ultrasound evidence of diastolic limitation or increased filling pressures, with at least two of the following diagnostic criteria: 4-1: E/A > 1.5 or a decrease in E/A > 0.5 during Valsalva maneuvers 4-2: Peak deceleration time = 140 ms. 4-3: Systolic pulmonary venous flow rate less than diastolic (PVs 40 mmHg 4-6: Evidence of left ventricular hypertrophy (5) LV mass/BSA = 96 in women or = 116 g/m2 in men (6) Relative ventricular wall thickness = 0.43 (7) LV posterior wall thickness = 0.9 in women or = 1.0 cm in men 9 Self-mobility without the use of a wheelchair, scooter, wheeled walking frame, or crutches.

Exclusion criteria

Exclusion criteria: 1, Any reason for not being able to cooperate with the study or the investigator thinks it is not suitable to be included in this trial 2, Having any of the following medical history, past history: (1) Hospitalization for HF within the past 3 months. (2) Acute coronary syndrome as determined by ECG changes or markers of myocardial injury (e.g., troponin) within the past three months. (3) PCI, CABG, or biventricular pacing within the past 3 months (4) Primary hypertrophic cardiomyopathy (5) Infiltrative cardiomyopathy (amyloidosis) (6) constrictive pericarditis or pericardial tamponade (7) Active myocarditis (8) Complex congenital heart disease (9) Active vascular disease (10) more than mild aortic or mitral stenosis (11) Moderate to severe valvular disease (prolapse, rheumatic) or severe mitral, tricuspid, or aortic regurgitation (12) Severe acute or chronic liver disease supported by any of the following: hepatic encephalopathy, varicose veins, hemorrhage, INR > 1.7 in the absence of anticoagulation. 3, Any of the following symptoms or signs (1) Severe COPD or ischemia resulting in dyspnea (2) Dyspnea due to ischemia (3) Blood pressure and heart rate meet one of the following: - SBP 180 mmHg - DBP 100 mmHg - Resting heart rate > 110 bpm 4, Laboratory tests meet any of the following: (1) Hemoglobin less than 8.0 g/dl (2) GFR < 20 ml/min/1.73 m2 in the most recent test report. 5, An ejection fraction in the range of less than 45% as determined by imaging. 6, Comorbid terminal disease other than HF with a life expectancy of less than one year 7, Enrollment or planned enrollment in other therapeutic clinical trials in the next three months. 8, Inability to comply with the planned study protocol

Design outcomes

Primary

MeasureTime frame
BCAAs;PP2cm;BCAT1;BCAT2;RNA-seq analysis result;Blood single-cell sequencing analysis result;

Countries

China

Contacts

Public ContactTao Li

West China Hospital, Sichuan University

scutaoli1981@scu.edu.cn+86 189 8060 6762

Outcome results

None listed

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