Clinical efficacy of electroacupuncture at acupoints below elbow-hand shaoyin/Jueyin meridian on improving chronic heart failure (acute exacerbation) -- A multicenter, randomized and controlled trial

Early Phase 1

Recruiting

• Conditions: Chronic heart failure

• Registration Number: ITMCTR2024000082
• Lead Sponsor: Department of Cardiovascular Medicine, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The age is 30~79 years old, regardless of gender.
2. Meet the diagnostic criteria of chronic heart failure:
1)LVEF=50% (improved Simpson method);
2) Have a history of heart disease;
3) With or without symptoms/signs of heart failure such as dyspnea, fatigue and fluid retention (edema).
3 suffering from a history of heart failure or clinical symptoms of heart failure for more than 3 months.
4. Acute exacerbation criteria of chronic heart failure
1) Symptoms: Patients with stable cardiac function have unexplained fatigue or significantly reduced exercise endurance; Difficulty in breathing due to exertion, paroxysmal dyspnea at night, and the need to raise the head with a pillow when sleeping; Sudden severe dyspnea, sitting breathing, wheezing, irritability and fear.
2) Signs: Left ventricle was found to be larger than before; The basal heart rate is 15-20 beats/min faster than before; Smell the law of running horses; There are wet rales, dry and wet rales and wheezing sounds in both lungs, especially at the bottom of the lungs. The above situation has changed dynamically.
Acute exacerbation is considered if you have any of the above items.
5. Nyha cardiac function grade III and above;
6. BNP = 100 pg/ml or NT-probnp = 300 pg/ml;
7. Percutaneous acupoint electrical stimulation can be accepted;
8. Sign the informed consent form.

Exclusion Criteria

1. The first acute heart failure.
2. One of the following diseases: ? within 30 days of acute coronary syndrome; ? within 6 months of revascularization; ? Hypertension (systolic blood pressure =180mmHg and/or diastolic blood pressure = 110mmhg) which is difficult to control with drugs; (4) uncontrollable malignant arrhythmia caused by sinus or atrioventricular block with degree ? or above without pacemaker; ? Pericardial tamponade; ? Active pericarditis; ? myocarditis; 8 pulmonary embolism; Pet-name ruby serious valve disease; Attending cor pulmonale; ?11 Stroke patients in recent 6 months, etc.
3. Cardiac resynchronization therapy.
4. Intravenous use of diuretic, cardiotonic and vasodilator drugs in the past 3 days.
5. alanine aminotransferase > 2 times the upper limit of normal ULN (upper limit of normal value).
6. serum creatinine > 265 umol/l. .
7. Patients with severe endocrine diseases such as hyperthyroidism.
8. Hemoglobin =9g/dl.
9. Mental patients.
10. Patients with malignant tumors.
11. Pregnant or planned pregnant women, lactating women.
12. Those with bleeding tendency, allergic skin or infectious skin diseases.
13. Participate in other researchers in the last two months.
14. Those who are unable to carry out the 6-minute walking test due to physical impairment or other reasons.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified