Last updated: January 30, 2024
Sponsor: Xinjiang Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Congestive Heart Failure
Hyponatremia
Chest Pain
Treatment
Renal denervation and maintenance of heart failure medications
Sham procedure and maintenance of heart failure medications
Clinical Study ID
NCT05715697
20230126-03
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- signs or symptoms of heart failure;
- normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
- evidence of diastolic LV dysfunction.
- Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHgand/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. Thistreatment is expected to be maintained for at least 6 months. Using this regimen theblood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BPmeasurement).
- Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimumof 2 weeks prior to enrollment, and which is expected to be maintained for at least 6months.
Exclusion
Exclusion Criteria:
- Known secondary cause of hypertension
- Anatomy not eligible for renal denervation
- Systolic heart failure (LVEF < 50%)
- Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2,using the MDRD calculation.
- Individual has any serious medical condition, which in the opinion of theinvestigator, may adversely affect the safety and/or effectiveness of the participantor the study (i.e., patients with clinically significant peripheral vascular disease,abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia,significant anaemia, or arrhythmias such as atrial fibrillation).
- Individual is pregnant, nursing or planning to be pregnant.
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Renal denervation and maintenance of heart failure medications
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
September 01, 2026
Study Description
Connect with a study center
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang 830000
ChinaActive - Recruiting
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