Qing-Xin Jie-Yu Granules on cardiopulmonary function for patients with heart failure with preserved ejection fraction: a randomized controlled trial

Phase 1

Not yet recruiting

• Conditions: heart failure with preserved ejection fraction

• Registration Number: ITMCTR2000002900
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

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

Inclusion Criteria

1. Both genders aged 40-70 years;
2. Patients with chronic heart failure, NYHA II-III,can complete cardiopulmonary exercise test, whose medications had not been adjusted whthin 2 weeks;
3. LVEF >= 50%;
4. NT-proBNP >= 400pg/mL;
5. Patients signed the written informed consent.

Exclusion Criteria

1. LVEF < 50% at any time in the past;
2. Solely right heart failure due to lung disease;
3. Short breath caused by non-cardiac diseases, such as lung disease, anemia, severe obesity, primary valvular heart disease, and cardiomyopathy;
4. Patients with cardio-cerebrovascular disease are planed to undertake revascularization therapy in three months;
5. Patients with serious primary diseases, such as liver, kidney and hematopoietic system, psychosis and severe neurosis;
6. Patients with uncontrolled hypertension(systolic pressure >= 160mmhg, or diastolic pressure >= 100mmhg);
7. Recent recurrence of malignant arrhythmia (paroxysmal ventricular tachycardia);
8. Pregnant, planned pregnant or lactating women
9. Those who participated in other clinical trials in the past 1 month;
10. Allergic constitution or allergy to known ingredients of the test drug.

Study & Design

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