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Correlation between peripheral blood ketone body and proinflammatory cytokins levels and mitochondrial function of mononuclear cells in HFpEF patients,an observational study

Correlation between peripheral blood ketone body and proinflammatory cytokins levels and mitochondrial function of mononuclear cells in HFpEF patients,an observational study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027938
Enrollment
Unknown
Registered
2019-12-06
Start date
2019-12-06
Completion date
Unknown
Last updated
2019-12-10

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

NHF:none
HFpEF:none

Sponsors

Sichuan University, West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. male or female aged >= 60 years old, 2. informed consent gave. 3. No initiation or cessation of any following drugs during the past 30-day regimenACEIARBß-receptor blockerCCB and Aldosterone antagonist. The Dosage adjustment of mentioned drugs does not exceed 100%. 4. Symptoms and signs of chronic heart failure (NYHA class II -IV). 5. Heart failure is the major factor of activity limitation. 6. LVEF >= 50%. 7. No continuous nitrate medication in the past 3 months or infrequent (less than once a week) intermittent sublingual administration of nitroglycerin. 8. Any occurance of the following situations in the past 12 months. (1). BNP > 200 pg/ml or NT-proBNP> 400 pg/ml. (2). Hospitalization for HF in the pastwith Imaging findings of pulmonary congestion. (pulmonary venous hypertension, vascular blockage, interstitial edema, pleural effusion). (3). LVEDP>= 15mmHg or PCWP>= 20mmHg at rest, or PCWP > 25mmHg during exercise. (4). Echocardiographic indications of diastolic dysfunction or increased filling pressure, with at least two of the following diagnostic criteria: (4-1) E/A > 1.5 or the E/A reduced > 0.5 during Valsalva Maneuver. (4-2) Peak deceleration time = 15. (4-4) Moderate left atrial enlargement. (4-5) Pulmonary artery systolic blood pressure > 40 mmHg. (4-6) left ventricular hypertrophy. (5) LV mass/BSA >= 96g/m2 (female) or >= 116g/m2 (male). (6) Relative wall thickness >= 0.43mm. (7) Left ventricular posterior wall thickness >= 0.9cm (female) or 1.0 cm (male). 9. unrelying on wheelchairs, flat cars, wheeled walkers or crutches.

Exclusion criteria

Exclusion criteria: 1. Incooperation with the study out of any reason or the investigator considers it inappropriate if included; 2. Any of the following past medical history: Hospitalization for HF during the past 3 months; Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery, or percutaneous coronary; intervention (PCI) during the past 3 months; Primary hypertrophic cardiomyopathy; infiltrative cardiomyopathy(amyloidosis); Constrictive pericarditis or pericardial tamponade; Active myocarditis; Complex congenital heart disease; Active vascular disease; Mild to severe aortic or mitral stenosis; Moderate to severe valvular disease (prolapse, rheumatism) or severe mitral, tricuspid, or aortic regurgitation; Severe acute or chronic hepatic disease as determined by any one of the following: hepatic encephalopathy, varicose veins, bleeding, INR > 1.7 without anticoagulant therapy. 3. Any of the following symptoms or signs: (1) Severe COPD or dyspnea caused by ischemia; (2) Blood pressure and heart rate match one of the following: (2-1): Systolic blood pressure > 180 mmHg or 100 mmHg; (2-3): Resting heart rate > 110 bpm 4. The laboratory examination conforms to any of the following: (4-1): Hemoglobin (Hgb) < 8.0 g/dl; (4-2): Chronic Kidney Disease with GFR< 20 ml/min/1.73 m2. 5. Any prior echocardiographic measurement of LVEF value < 45%; 6. Any Comorbidity with a life expectancy < 1 year; 7. Enrolled or planned to enroll in other therapeutic clinical trials in the next three months; 8. Non- adherence to medical regimens.

Design outcomes

Primary

MeasureTime frame
ß-OHB;IL1ß;IL18;TNF-a;OCR;ECAR;

Countries

China

Contacts

Public ContactQian Li

Sichuan University West China Hospital

hxliqian@foxmail.com+86 18980601635

Outcome results

None listed

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